NA 391.882Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982198341), received between May 7, 2019 and Nov 28, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Maintain” (1 report).

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.

• MalfunctionNov 28, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT THE CRIMPER IS NOT CRIMPING CABLES. TEETH AREA NOT CLOSING. IT IS UNKNOWN IF SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. THIS REPORT IS FOR ONE CABLE CRIMPER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868781 ↗
• MalfunctionAug 2, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE CABLE CRIMPER MECHANISMS WAS NOT HOLDING ANYMORE AND IT LOOKS LIKE THE TOOTH ON THE CRIMPER WAS BENT OR CHIPPED OFF. IT IS UNKNOWN IF THERE WERE PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8857145 ↗
• MalfunctionMay 7, 2019Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED THAT ON (B)(6) 2019, AFTER A CASE DONE OVER THE WEEKEND, THE SURGEON WAS DOING A HEMIARTHROPLASTY. THE SURGEON NEEDED A CABLE TO SECURE POTENTIAL PENDING FRACTURE, BUT WHEN THE SURGEON WENT TO CRIMP THE CABLE, THE CABLE CRIMPER WAS NOT WORKING IT WOULD NOT HOLD THE CRIMPER IN PLACE. SO ANOTHER SET WAS OPENED AND ANOTHER CRIMPER WAS USED. NO DELAYED TO THE CASE. CONCOMITANT DEVICE REPORTED: UNK - CABLE/WIRE ACCESSORIES: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586757 ↗