FASTIN ORTHOCORD 222993Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10886705008711), received between Aug 16, 2018 and Sep 21, 2026 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (13 reports).

1 other recall cover devices cleared under the same FDA submission (K041075, K060664); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846571 ↗
• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788470 ↗
• MalfunctionMay 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE IT WAS OBSERVED THAT THE FASTIN RC 5MM OCORD W/O NDLS ANCHOR INSERTER DID NOT RELEASE FROM THE ROD, EVEN WHEN USING THE CORRECT TECHNIQUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107659 ↗
• MalfunctionApr 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A LABRAL TEAR REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE FASTIN RC 5MM OCORD W/O NDLS DEVICE ANCHOR DID NOT DETACH CORRECTLY FROM THE ROD WHEN TRYING TO FIX THE ANCHOR IN THE PATIENT'S SHOULDER MAKING IT IMPOSSIBLE TO ANCHOR IT IN THE BONE STRUCTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS AN UNSPECIFIED DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21737393 ↗
• MalfunctionNov 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A LATERAL RESECTION AND REMOVAL OF MATERIAL PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR THREAD ON THE FASTIN RC 5MM OCORD W/O NDLS DEVICE FAILED TO DETACH FROM THE INSERTION ROD, DESPITE MULTIPLE ATTEMPTS DURING THE PROCEDURE. THE ISSUE CONTINUED EVEN OUTSIDE THE SURGICAL SETTING, WITH SEVERAL MANUAL ATTEMPTS UNABLE TO SEPARATE THE THREAD FROM THE ROD. VISUALLY, THE COMPONENT PRESENTED A POSSIBLE FUSION BETWEEN THE ANCHOR AND THE INSERTION BODY, COMPROMISING THE SAFE AND EFFECTIVE USE OF THE DEVICE. THE SURGICAL TECHNIQUE WAS ADAPTED, AND SAMPLE SEGREGATION WAS IMPLEMENTED TO MINIMIZE ANY IMPACT ON THE EXPECTED OUTCOME OF THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588787 ↗
• MalfunctionOct 24, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED FROM BRAZIL THAT DURING A ACROMIOPLASTY AND CUFF RUPTURE REPAIR PROCEDURE, IT WAS DISCOVERED THAT THERE WAS SIGNIFICANT DIFFICULTY RELEASING THE ANCHOR FROM THE FASTIN RC 5MM OCORD W/O NDLS DEVICE AFTER IT WAS INSERTED, DESPITE MULTIPLE ATTEMPTS. AS A RESULT, THE ANCHOR BECAME STUCK IN THE APPLICATOR AND FRACTURED INSIDE THE PATIENT, INCREASING THE COMPLEXITY OF THE INTERVENTION. DESPITE THIS ISSUE, THE PROCEDURE WAS COMPLETED WITHOUT THE NEED TO REPLACE THE ANCHOR, AND NO IMMEDIATE SERIOUS COMPLICATIONS AFFECTING THE PATIENT¿S HEALTH OCCURRED DURING THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524654 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN BRAZIL THAT ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FASTIN RC 5MM OCORD W/O NDLS DEVICE HAD A SHRED PROBLEM DURING THE PROCEDURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927057 ↗
• MalfunctionMay 2, 2024Migration; Migration

  IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE FASTIN RC 5MM OCORD W/O NDLS DEVICE PULLED OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229179 ↗
• MalfunctionJun 7, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  THIS IS REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THERE WAS A PINHOLE IN THE FOIL WRAPPING OF THE FASTIN RC 5MM ORTHOCORD W/O NEEDLES DEVICE. ACCORDING TO THE REPORT, THE ISSUE WAS NOTICED UPON OPENING THE PACKAGE OF THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081151 ↗
• MalfunctionJun 7, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THERE WAS A PINHOLE IN THE FOIL WRAPPING OF THE FASTIN RC 5MM ORTHOCORD W/O NEEDLES DEVICE. ACCORDING TO THE REPORT, THE ISSUE WAS NOTICED UPON OPENING THE PACKAGE OF THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081150 ↗
• MalfunctionJun 7, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  THIS IS REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THERE WAS A PINHOLE IN THE FOIL WRAPPING OF THE FASTIN RC 5MM ORTHOCORD W/O NEEDLES DEVICE. ACCORDING TO THE REPORT, THE ISSUE WAS NOTICED UPON OPENING THE PACKAGE OF THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081149 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A FASTIN RC 5MM ORTHOCORD W/O NEEDLES DEVICE WAS USED. ACCORDING TO THE REPORT, THE PATIENT SHOWED POSTOPERATIVELY AN ALLERGIC REACTION TO THE ANCHOR DUE TO THE METALLURGICAL COMPOSITION. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16993739 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, A FASTIN RC 5MM ORTHOCORD W/O NEEDLES DEVICE WAS USED. ACCORDING TO THE REPORT, THE PATIENT SHOWED POSTOPERATIVELY AN ALLERGIC REACTION TO THE ANCHOR DUE TO THE METALLURGICAL COMPOSITION. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16993644 ↗
• MalfunctionApr 12, 2023Break; Break

  THIS IS REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO PLATES ON THE TRUESPAN MENISCAL REPAIR SYSTEM PEEK 12 DEGREE DEVICE WERE DEPLOYED AT THE SAME TIME AFTER THE FIRST FIRING. CHANGED TO ANOTHER TRUESPAN MENISCAL REPAIR SYSTEM PEEK 12 DEGREE DEVICE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO TRUESPAN MENISCAL REPAIR SYSTEM PEEK 24 DEGREE DEVICE TO CONTINUE THE SURGERY BUT ITS SUTURE BROKE OFF WHEN TIGHTENED THE SUTURE. AND THEN USE FASTIN RC 5MM ORTHOCORD W/O NEEDLES DEVICE BUT ITS SUTURE ALSO BROKE OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726348 ↗
• MalfunctionMar 31, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN BRAZIL THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE FASTIN RC 5MM ORTHOCORD W/O NEEDLES DEVICE WAS NOT RELEASED FROM THE APPLICATOR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657231 ↗
• MalfunctionDec 29, 2022Difficult to Advance; Difficult to Advance

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT TWO FASTIN RC 5MM ORTHOCORD W/O NEEDLES DEVICES COULD NOT BE SCREWED IN PROPERLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075260 ↗
• MalfunctionDec 29, 2022Difficult to Advance; Difficult to Advance

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT TWO FASTIN RC 5MM ORTHOCORD W/O NEEDLES DEVICES COULD NOT BE SCREWED IN PROPERLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075233 ↗
• MalfunctionDec 16, 2022Migration; Migration

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE FASTIN RC 5MM ORTHOCORD W/O NEEDLES DEVICE PULLED OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996076 ↗
• MalfunctionOct 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE THREADS ON THE ANCHOR ON THE FASTIN RC 5MM OCORD W/O NDLS DEVICE WAS NOT PROPERLY THREADED INTO THE INSERTER. ACCORDING TO THE REPORT, THE SURGEON INSTALLED THE ANCHOR BUT NOTED THAT THE THREADS WERE WOUND ON THE INSERTER DURING IMPLEMENTATION THAT IT CREATED DIFFICULTIES IN THE MANIPULATION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605647 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT THE SUTURE ON THE FASTIN RC 5MM OCORD W/O NDLS SNAPPED WHILE ATTEMPTING TO TIE MEDIAL KNOTS WHICH HAD TO BE PULLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393629 ↗
• MalfunctionMay 20, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT AFTER A REFIXATION BICEPS-TENDON ON THE RADIUS PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE FASTIN RC 5MM ORTHOCORD W/O NEEDLES WAS DISLOCATED. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855292 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN BRAZIL THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE ON THE FASTIN RC 5MM OCORD W/O NDLS ANCHOR DEVICE BROKE WHILE TYING A KNOT. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797857 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN BRAZIL THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE ON THE FASTIN RC 5MM OCORD W/O NDLS ANCHOR DEVICE BROKE WHILE TYING A KNOT. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797846 ↗
• MalfunctionOct 19, 2020Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING THE SURGERY OF SUTURING RIGHT ROTATOR CUFF INJURY, AFTER INSERT THE ANCHOR, WHEN TIGHTENED THE SUTURE, THE SUTURE WAS BROKEN OFF AND THE ANCHOR WAS PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGEON IS VERY EXPERIENCED WITH OUR PRODUCT, 1ST TIME FACED WITH THIS ISSUE. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10701750 ↗
• MalfunctionSep 9, 2020Migration; Migration

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2020, IT WAS OBSERVED THAT TWO ANCHOR DEVICES PULLED OUT OF THE BONE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY WITH A COUPLE OF MINUTES DELAY. THERE WAS AN ALTERNATIVE PRODUCT READILY AVAILABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10508778 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041075, K060664. One submission often covers many models, so check the product and lot details in each record.

• Z-0446-06 · Oct 27, 2005 · Terminated
  Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740