Arthrex® AR-1370BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867014626), received between Dec 27, 2017 and Jul 8, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2019Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE SCREW WOULD ONLY ENTER HALFWAY INTO THE BIO-INTERFERENCE SCREW, AR-1370B. THE SURGEON TRIED 2 OTHER SCREWDRIVERS AND THIS DID NOT WORK. THE GRAFT WAS FIXED INTO THE TIBIAL TUNNEL WITH AN INTERFERENCE SCREW AND THE SCREW ENTERED WAS DIVIDED HALFWAY OUTSIDE AND INSIDE BONE. NO FURTHER INFORMATION PROVIDED. FURTHER INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2019: THE PROCEDURE BEING PERFORMED WAS A REPAIR OF ANTERIOR CRUCIATE LIGAMENT. BONE QUALITY WAS REPORTED TO BE HARD. THE PIECE THAT BROKE WAS NOT FULLY RETRIEVED. THE CASE WAS COMPLETED BY USING A SECOND SCREW OF A LARGER DIAMETER TO FIX THE GRAFT IN THE TIBIAL AREA. THE SURGEON HAD TO SWITCH TO ANOTHER SURGICAL TECHNIQUE WHICH WAS A SEMITENDINOSUS AUTOLOGOUS GRAFT USED WITH INTERFERENCE FIXATION IN THE TIBIA AND FEMUR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8769047 ↗
• InjuryJan 23, 2019Break

  IT WAS REPORTED THAT A AR-1370B SCREW WAS USED DURING "A" ACL SURGERY AND REMOVED BECAUSE IT WAS BROKEN. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. INFORMATION WAS REQUESTED IF ALL BROKEN OFF PARTS COULD BE REMOVED. UPDATE 02 JANUARY 2019: THE SCREW BROKE INTO THE FEMUR DURING THE FIRST TURNS WITHOUT EXCESSIVE FORCE. THE SURGEON THEN REALIZED THAT THE SCREWDRIVER WAS NOT AT THE BOTTOM OF THE SCREW BECAUSE IT WAS BLOCKED. IT WAS NOT POSSIBLE TO REMOVE THE BROKEN FRAGMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270464 ↗
• InjuryDec 27, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A CYST FOLLOWING THE IMPLANTATION OF A BIO-ABSORBABLE SCREW AR-1390B 9 MM X 23 MM, 3 YEARS BEFORE. IMPLANTATION OF THE SCREW ON (B)(6) 2014, REMOVAL ON (B)(6) 2017. HISTOPATHOLOGICAL SAMPLING PERFORMED. FOLLOW-UP INVESTIGATION: THE SURGEON ALSO USED 2 FASTFIX. THE SURGERY WAS AN ACL RECONSTRUCTION. IMPLANTED DEVICES: AR-1555BC LOT.:1189552; AR-1370B LOT: 1188967 AND AR-1390B LOT: 1189199.

  Patient problems: Cyst(s)

  MAUDE report 7147536 ↗