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HammerLock2 HL2LARecalls & reported problems

Synthes GmbH · HammerLock2 15mm Proximal – 7mm Distal Implant, Angled · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810633021453), received between Oct 19, 2018 and Mar 14, 2019 — classified as 3 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2
  • Packaging Problem1

Patient problems

  • No Patient Involvement2
  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMar 14, 2019Packaging Problem; Packaging Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) HAMMERLOCK 2 IMPLANT ANGLED LARGE BOXES WERE DAMAGED WHICH COULD CAUSE POSSIBLE CONTAMINATION OF THE IMPLANT. THE HAMMERLOCK 2 IMPLANT LARGE AND HAMMERLOCK 2 IMPLANT SMALL HAVE COME OFF THE INSERTER. THE SPEED TITAN COMPRESSION IMPLANT BROKE THROUGH THE UNKNOWN INSERTER. THE PACKAGES OF THE SPEEDARC COMPRESSION IMPLANT AND SPEEDTRAID IMPLANT SIZING GUIDE WERE DAMAGED AND COULD CAUSE POSSIBLE CONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTER (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1). THIS REPORT IS FOR ONE (1) HAMMERLOCK 2 IMPLANT KIT 15X7MM/10 DEGREES/LARGE. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8420857 ↗
  • MalfunctionFeb 28, 2019Break; Break

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, A HAMMERLOCK 2 IMPLANT ANGLED LARGE WAS DISCOVERED BROKEN INSIDE THE PACKAGE. THE PACKAGE WAS NEVER OPENED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Patient problems: No Patient Involvement

    MAUDE report 8379325 ↗
  • MalfunctionOct 19, 2018Break; Break

    UPDATE,10.12.2018: THE DEVICES INVOLVED IN THIS COMPLAINT WERE RECEIVED BY BME ON OCT.12, 2018.

    Patient problems: No Patient Involvement

    MAUDE report 7984981 ↗

Other Pin, Fixation, Smooth devices

All Pin, Fixation, Smooth devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.