Double Fix Knotless PK 72290143Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00885556722497), received between Nov 27, 2018 and Mar 13, 2025 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE DOUBLE FIX PK SUTURE WAS INSERTED INTO THE ANCHOR, THE WIRE OF SUTURE THREADER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY, BUT IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597230 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, WHEN INSERTING THE DOUBLE FIX KNOTLESS ANCHOR INTO THE FEMORAL HEAD, THE ANCHOR WAS FRACTURED. ALL THE PIECES WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594262 ↗
• MalfunctionAug 23, 2024Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE DOUBLE KNOTLESS ANCHOR WAS INSERTED INTO THE BONE HOLE, THE ANCHOR WAS BROKEN, THE DISTAL END CAP FELL OFF FROM THE HANDLE AND THE DEPLOYMENT KNOB COULD NOT BE TWISTED. ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY OF 2 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20056302 ↗
• MalfunctionDec 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE DOUBLE FIX KNOTLESS PK PRESENTED AN ISSUE. UPON INSERTION INTO THE JOINT, WHEN THE SUTURE WAS BEING PASSED THROUGH THE ANCHOR, THE DEVICE FRACTURED; ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. SURGERY CONTINUED WITHOUT ANY DELAY; HOWEVER IT IS UNKNOWN HOW IT WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378051 ↗
• InjuryJun 3, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE WIRE OF THE DOUBLE FIX KNOTLESS THREADER WAS BROKEN, THE DEVICE COULD NOT BE USED. THE DEVICE BROKE INSIDE THE PATIENT AND ALL THE PIECES WERE REMOVED. IT IS UNKNOWN HOW WERE THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO DELAY AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11936067 ↗
• InjuryJun 3, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE WIRE OF THE DOUBLE FIX KNOTLESS THREADER WAS BROKEN, THE DEVICES COULD NOT BE USED. THE DEVICE BROKE INSIDE THE PATIENT AND ALL THE PIECES WERE REMOVED. IT IS UNKNOWN HOW WERE THEY REMOVED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO DELAY AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11936054 ↗
• InjuryJun 3, 2021Break; Break

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE THE PATIENT IN AN ARTHROSCOPY PROCEDURE, THE WIRE OF THE THREADER WAS BROKEN. THE BROKEN PIECE WAS LEFT IN THE BODY AFTER SURGERY. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11931008 ↗
• InjuryOct 27, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LABRUM REPAIR WITH ROTATOR CUFF TEAR PROCEDURE, WHEN BRIDGED IN NORMAL USE, THE METAL TIP OF THE INSERTER BROKE OFF AND REMAINED INSIDE THE ANCHOR. THE METAL PIECE WAS NOT RETRIEVED FROM THE PATIENT'S ANATOMY. NO DELAY REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE WITH NO OTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10738625 ↗
• InjuryOct 18, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LABRUM REPAIR WITH ROTATOR CUFF TEAR PROCEDURE, WHEN BRIDGED IN NORMAL USE, THE METAL TIP OF THE INSERTER BROKE OFF AND REMAINED INSIDE THE ANCHOR. THE METAL PIECE WAS NOT RETRIEVED FROM THE PATIENT'S ANATOMY. NO DELAY REPORTED. SURGERY WAS COMPLETED USING THE SAME DEVICE WITH NO OTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10694732 ↗
• InjurySep 26, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ARCR PROCEDURE, THE DOUBLE FIX ANCHOR BROKE WHEN IT WAS BEING INSERTED IN THE BONE HOLE. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10591145 ↗
• InjuryJul 9, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE,THE SCREW WAS BROKEN WHEN THE DEVICE WAS USED USUAL. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10250935 ↗
• MalfunctionApr 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING ITERATIVE SHOULDER DISLOCATION AND ROTATOR CUFF TEAR PROCEDURE THE DOUBLE FIX KNOTLESS PK'S ANCHOR BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT. A NEW BONE HOLE WAS MADE AND A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A 10 MIN DELAY. NO INJURY TO THE PATIENT WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9936582 ↗
• MalfunctionAug 6, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE DEPLOYMENT KNOB WAS ROTATED, THE SCREW COULD NOT BE INSERTED IN THE BONE HOLE. AFTER THAT, THE KNOB WAS RETURNED TO THE ORIGINAL POSITION AND IT COULD BE DEPLOYED. IT WAS NOTICED BY X-RAY THAT THE TIP OF THE INSERTER BROKE AND REMAINS IN THE ANCHOR INSIDE THE PATIENT. THERE WAS NO DELAY. NO HEALTH HAZARDS HAVE BEEN REPORTED FOR THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8867849 ↗
• MalfunctionJun 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE DOUBLE FIX KNOTLESS IMPLANT BROKE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT BUT IT IS UNKNOWN WHAT MEDICAL TECHNIQUE WAS USED. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT SIGNIFICANT DELAY. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8665041 ↗
• MalfunctionDec 24, 2018Break

  IT WAS REPORTED THAT DURING ARTICULAR LABRUM REPAIR/ARCR PROCEDURE, THE SCREW PART OF THE INSERTER BROKE OFF. PIECES WERE RETRIEVED FROM THE PATIENT. THERE WAS A 30 MINUTE DELAY AND THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8194394 ↗
• MalfunctionDec 11, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ARTICULAR LABRUM REPAIR/ARCR PROCEDURE, THE TIP OF INSERTER WAS CHECKED AND FOUND BROKEN OFF. THE BROKEN TIP WAS CONFIRMED AT X-RAY. REMAINING PARTS OF THE SCREW (OF THE INSERTER) WERE RETRIEVED BUT OTHER PARTS WERE REMAINED IN THE PATIENT. THERE WAS A 30 MINUTE DELAY AND THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8153115 ↗
• MalfunctionDec 11, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT THE IMPLANTED ANCHOR CAME OUT FROM THE SITE. A SURGICAL DELAY OF 2 HOURS TO REMOVE THE ANCHOR WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8151128 ↗
• MalfunctionDec 11, 2018Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IMMEDIATELY AT SAME DAY WITH A SURGICAL DELAY OF 2 HOURS TO REMOVE THE ANCHOR, AND ROTATOR CUFF WAS FIXED WITH HEALICOIL. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8151085 ↗
• MalfunctionDec 5, 2018Break; Device Fell

  IT WAS REPORTED THAT DURING ARCR PROCEDURE, THE ANCHOR BROKE OFF FROM THE BASE. THE SCREW PARTS DROPPED OFF INSIDE THE JOINT, BUT IT WAS REMOVED WITH GRASPER. NO PATIENT INJURY WAS REPORTED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8134324 ↗
• InjuryDec 5, 2018Break

  IT WAS REPORTED THAT POST PRIMARY ARCR PROCEDURE, IT WAS NOTICED THAT TIP OF INSERTER BROKE AND REMAINS IN THE ANCHOR BY X-RAY. ALSO, THE IMPLANTED ANCHOR CAME OUT FROM THE SITE. REVISION SURGERY WAS PERFORMED IMMEDIATELY AT SAME DAY TO REMOVE THE ANCHOR, AND ROTATOR CUFF WAS FIXED WITH A BACKUP DEVICE, A HEALICOIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8133527 ↗
• MalfunctionNov 27, 2018Break; Device Slipped

  IT WAS REPORTED THAT DURING ARCR PROCEDURE, WHILE SELF-TAP INSERTION, TIP OF INSERTER SLIPPED AND BROKE DUE TO PATIENT BONE QUALITY HARD. BACKUP DEVICE WAS USED. NO PATIENT INJURY OR DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8108188 ↗