DHHS 338.348Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982193438), received between Apr 4, 2018 and Dec 28, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BARREL PLATE WOULDN'T SEAT OVER BLADE AND BOTH IMPACTOR CAP TIP BROKE IN THE PROCESS. I'M NOT SURE WHICH ONE WAS AT FAULT SO I WILL GIVE YOU THE NUMBERS FOR THEM ALL. NOTHING WAS LEFT IN THE PATIENT. ENDED UP REMOVING EVERYTHING AND USING CANNULATED SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN NUMBER OF SURGICAL DELAYS. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) LCP® DHHS(TM) IMPACTOR CAP. THIS REPORT IS 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11079908 ↗
• InjuryDec 28, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BARREL PLATE WOULDN'T SEAT OVER BLADE AND BOTH IMPACTOR CAP TIP BROKE IN THE PROCESS. I'M NOT SURE WHICH ONE WAS AT FAULT SO I WILL GIVE YOU THE NUMBERS FOR THEM ALL. NOTHING WAS LEFT IN THE PATIENT. ENDED UP REMOVING EVERYTHING AND USING CANNULATED SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN NUMBER OF SURGICAL DELAYS. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) LCP® DHHS(TM) IMPACTOR CAP. THIS REPORT IS 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11079898 ↗
• MalfunctionMay 16, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE LOCKING COMPRESSION PLATE (LCP) DHHS IMPACTOR CAP WAS BROKEN DURING THE CASE. FRAGMENTS WERE GENERATED BUT EASILY REMOVED. THERE WAS NO SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR AN IMPACTOR CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8617009 ↗
• MalfunctionApr 4, 2018Break; Break

  IT WAS REPORTED THAT DURING A OPEN REDUCTION INTERNAL FIXATION (ORIF) HIP PROCEDURE USING THE DHHS SYSTEM ON AN UNKNOWN DATE IN 2018, THE TIP OF THE IMPACTOR BROKE WHILE HITTING IT IN ITS INTENDED MANOR. THE IMPACTOR AND BROKEN PIECE WAS REMOVED WITHIN THIRTY (30) SECONDS AND THE CASE CONTINUED. THE SURGICAL STAFF WAS INSTRUCTED TO PUT THE SECOND IMPACTOR CAP ON THE IMPACTOR, WHERE THE SURGEON CONTINUED THE PROCEDURE AND THIS ONE BROKE AS WELL. THE CAP AND THE BROKEN PIECE WERE REMOVED WITHIN APPROXIMATELY THIRTY (30) SECONDS, AND THE CASE CONTINUED. THE SURGICAL DELAY IN THE CASE WITH ONLY TWO TO THREE (2-3) MINUTES, AND IT DID NOT HAVE ANY EFFECT ON THE OUTCOME OF THE CASE OR THE PATIENT. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7395946 ↗
• MalfunctionApr 4, 2018Break; Break

  IT WAS REPORTED THAT DURING A OPEN REDUCTION INTERNAL FIXATION (ORIF) HIP PROCEDURE USING THE DHHS SYSTEM ON AN UNKNOWN DATE IN 2018, THE TIP OF THE IMPACTOR BROKE WHILE HITTING IT IN ITS INTENDED MANOR. THE IMPACTOR AND BROKEN PIECE WAS REMOVED WITHIN THIRTY (30) SECONDS AND THE CASE CONTINUED. THE SURGICAL STAFF WAS INSTRUCTED TO PUT THE SECOND IMPACTOR CAP ON THE IMPACTOR, WHERE THE SURGEON CONTINUED THE PROCEDURE AND THIS ONE BROKE AS WELL. THE CAP AND THE BROKEN PIECE WERE REMOVED WITHIN APPROXIMATELY THIRTY (30) SECONDS, AND THE CASE CONTINUED. THE SURGICAL DELAY IN THE CASE WITH ONLY TWO TO THREE (2-3) MINUTES, AND IT DID NOT HAVE ANY EFFECT ON THE OUTCOME OF THE CASE OR THE PATIENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7395837 ↗