TRUESPAN ORTHOCORD 228150Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 10886705026005), received between Jul 23, 2018 and Sep 22, 2026 — classified as 11 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (56 reports).

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 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Device-Device Incompatibility

  This is report 2 of 2 of (b)(4).It was reported that during a Meniscal Repair surgery, two TRUESPAN 0 DEGREE PEEK device failed to deploy. There was a five minute delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854939 ↗
• MalfunctionSep 22, 2026Device-Device Incompatibility

  This is report 1 of 2 of (b)(4).It was reported that during a Meniscal Repair surgery, two TRUESPAN 0 DEGREE PEEK device failed to deploy. There was a five-minute delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854938 ↗
• MalfunctionSep 17, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810306 ↗
• MalfunctionSep 10, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713993 ↗
• MalfunctionApr 8, 2026Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING THE ATTEMPT TO PERFORM THE SUTURE DURING THE MENISCAL REPAIR SURGERY, THE DART OF THE TRUESPAN PEEK IMPLANT JAMMED AT THE TIP ON THE FIRST ACTIVATION. THERE WERE NO SURGICAL DELAYS AND NO HARM TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820285 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY, MENISCAL SUTURE, THE TRIGGER OF THE TRUESPAN 0 DEGREE PEEK BROKE. THERE WERE NO REPORTS OF PATIENT OR USER HARM. NO WAS WAS NO SIGNIFICANT DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764725 ↗
• MalfunctionDec 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, IT WAS OBSERVED THAT THE TRUESPAN 0 DEGREE PEEK DEVICE IMPLANT DID NOT DEPLOY FROM THE INSERTION DEVICE. THERE WAS NO 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 23827317 ↗
• MalfunctionSep 19, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TRUESPAN 0 DEGREE PEEK DEVICE RED TRIGGER WAS BROKEN DURING INSERTION OF THE IMPLANT. THIS OCCURRED TWO TIMES WITH DIFFERENT GUNS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. THERE WERE FRAGMENTS GENERATED. THE FRAGMENTS WERE REMOVED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23101166 ↗
• MalfunctionSep 19, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TRUESPAN 0 DEGREE PEEK DEVICE RED TRIGGER WAS BROKEN DURING INSERTION OF THE IMPLANT. THIS OCCURRED TWO TIMES WITH DIFFERENT GUNS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE. THERE WERE FRAGMENTS GENERATED. THE FRAGMENTS WERE REMOVED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23101164 ↗
• MalfunctionAug 14, 2025Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, IT WAS OBSERVED THAT THE TRUESPAN 0 DEGREE PEEK DEVICE ACTIVATED PREMATURELY BEFORE BEING ABLE TO ANCHOR THE SUTURE, WHICH PREVENTED THE CORRESPONDING TECHNIQUE. THERE WAS NO 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 22804435 ↗
• MalfunctionAug 12, 2025Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE TWO (X2) TRUESPAN 0 DEGREE PEEK DEVICES WERE BEING USED WHEN ONE, THE POINT DID NOT TRIGGER WHEN THE TRIGGER WAS TRIGGER AND THE SECOND THE POINT WAS NOT FIXED AND REMOVED AND CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786196 ↗
• MalfunctionAug 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE TWO (X2) TRUESPAN 0 DEGREE PEEK DEVICES WERE BEING USED WHEN ONE, THE POINT DID NOT TRIGGER WHEN THE TRIGGER WAS TRIGGER AND THE SECOND THE POINT WAS NOT FIXED AND REMOVED AND CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786160 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER (B)(4) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX TIBIALSHEATH 30MM DEVICE, INTRAFIX TAPERSCR 8-10X30MM DEVICE AND TRUESPAN 0 DEGREE PEEK DEVICE FAILED AND THE PATIENT REQUIRED A RE-OPERATION OR REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. A COPY OF THIS REPORT IS TO THIS MEDWATCH REPORT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22621114 ↗
• MalfunctionMay 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE TRUESPAN 0 DEGREE PEEK DEVICE DID NOT FULLY EJECT. IT WAS NOT REPORTED WHETHER ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO 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 22060094 ↗
• MalfunctionJan 28, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHEN ATTEMPTING TO PLACE THE TRUESPAN 0 DEGREE PEEK SUTURE ALREADY LOCATED IN THE MEDIAL MENISCUS, IT WAS OBSERVED THAT THE TWO ANCHOR DEVICES CAME OUT, AND THE SUTURE COULD NOT BE PLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. . NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251439 ↗
• MalfunctionAug 28, 2024Premature Activation; Premature Activation

  IT WAS REPORTED BY THE SALES REP IN BRAZIL THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON ((B)(6) 2024 THE TRUESPAN 0 DEGREE PEEK DEVICE SUTURE MENISCUS FAILED TO DURING USE. WHEN THE TRIGGER TRIGGERED THE TWO SIMULTANEOUS DOCKING DEVICES, BEING UNABLE TO USE THE DISPOSABLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20088972 ↗
• MalfunctionMay 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A MENISCECTOMY PROCEDURE, IT WAS OBSERVED THAT THE TRIGGER ON THE TRUESPAN 0 DEGREE PEEK GOT STUCK ON THE FIRST AND SECOND SHOT RESULTING IN THE FAILURE TO SECURE THE WIRE IN THE PATIENT'S MENSICUS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229322 ↗
• MalfunctionApr 24, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED FROM MEXICO THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE TRUESPAN 0 DEGREE PEEK DEVICE WAS PASSED TO THE INFIRMARY AND GRADUATED TO 20MM DEPTH. THE DOCTOR TOOK IT AND INTRODUCED THE SYSTEM TO PLACE IT IN THE MENISCUS, THEN INTRODUCED THE NEEDLE AND PROCEEDED TO SHOOT IT WITH THE RED TRIGGER. HOWEVER, THE SYSTEM ENCOUNTERED RESISTANCE, AND WHEN SOME FORCE WAS APPLIED, THE MECHANISM BROKE AND BECAME UNUSABLE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE 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 19175582 ↗
• MalfunctionApr 10, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED BY THE SALES REP THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE TRUESPAN 12 DEGREE PEEK DEVICE IMPLANT FAILED TO DEPLOY AND BECAME BOUND UP. TWO OTHER DEVICES IMPLANTS FAILED TO DEPLOY AND WHEN THE HANDLE WAS SQUEEZED IT BECAME LOOSE AND WOULD NOT ENGAGE. THE SURGERY WAS DELAYED FOR TEN MINUTES. NO FRAGMENTS WERE GENERATED. THE DEVICE WAS REMOVED EASILY WITHOUT INTERVENTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082135 ↗
• MalfunctionApr 10, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED BY THE SALES REP THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE TRUESPAN 12 DEGREE PEEK DEVICE IMPLANT FAILED TO DEPLOY AND BECAME BOUND UP. TWO OTHER DEVICES IMPLANTS FAILED TO DEPLOY AND WHEN THE HANDLE WAS SQUEEZED IT BECAME LOOSE AND WOULD NOT ENGAGE. THE SURGERY WAS DELAYED FOR TEN MINUTES. NO FRAGMENTS WERE GENERATED. THE DEVICE WAS REMOVED EASILY WITHOUT INTERVENTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19082063 ↗
• MalfunctionFeb 8, 2024Crack; Device Damaged Prior to Use; Detachment of Device or Device Component; Crack; Device Damaged Prior to Use; Detachment of Device or Device Component

  IT WAS REPORTED FROM COLOMBIA THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2023 IT WAS OBSERVED THAT THE WHITE ELASTIC COVERING THE NEEDLE WAS BROKEN AND WITH THE SUTURE OUTSIDE ON THE TRUESPAN 0 DEGREE PEEK DEVICE UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTOS RECEIVED FROM THE CUSTOMER, IT WAS DETERMINED THAT THE A PARTIAL PART OF THE DEVICE WAS IN USED CONDITION WITH ONE OF THE ANCHOR ALREADY DEPLOYED, WHITE SLEEVE WAS DAMAGED AND WATER DROPS COULD BE SEEN ON THE SLEEVE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 18669893 ↗
• MalfunctionJan 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN CHILE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE PERFORMED ON (B)(6) 2023 WHEN THE PHYSICIAN WAS SUTURING THE PATIENT¿S MENISCUS THE FIRST TIME, THE TRIGGER OF THE TRUESPAN 12 DEGREE PEEK GUN DEVICE BROKE. IT WAS REPORTED THAT TWO ADDITIONAL PEEK DEVICES (TRUESPAN 12 DEGREE PEEK AND TRUESPAN 0 DEGREE PEEK) WERE USED AND FAILED (WOULD NOT DEPLOY). THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3 FOR THE SAME EVENT IN (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464665 ↗
• MalfunctionDec 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL (ANT. CRUCIATE LIGAMENT) UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE TRUESPAN 0 DEGREE PEEK DEVICE FIRST STITCH PULLED OFF FROM THE NEEDLE WHEN THE PHYSICIAN TRIED TO THE REPAIR THE MENISCUS. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18402377 ↗
• MalfunctionDec 8, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE AFFILIATE IN BRAZIL THAT DURING A TRUESPAN PEEK MENISCUS REPAIR IMPLANT, THE TRUESPAN 0 DEGREE PEEK SYSTEM PRESENTED PROBLEMS. IT WAS REPORTED THAT THE SECOND SHOT FAILED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THERE WAS NO SURGICAL DELAY REPORTED. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18295998 ↗
• MalfunctionSep 20, 2023Difficult to Advance; Difficult to Advance

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT TWO (2) TRUESPAN MENISCAL REPAIR SYSTEM PEEK 0 DEGREE DEVICES DEPLOYED BUT DID NOT STAY IN THE TISSUE; AND COULD NOT BE RELOADED. 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 17781982 ↗