ACET PUNCH
Received Jan 5, 2023 · Event occurred Dec 16, 2022
Report 1818910-2023-00488 · MDR key 16102218
Device
Generic name
Hip Instruments : Reamers
Manufacturer
Depuy Orthopaedics Inc UsModel number
6020-29-000Catalog number
602029000
Lot number
BG0898H
Product problems
- Break
- Break
Patient
62 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHESE JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHESE JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY : THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE CONFIRMED THE COMPLAINT. FRAGMENTS HAVE BROKEN OFF FROM THE HANDLE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED WHILE GAINING ACCESS TO THE FEMORAL CANAL FOR SLEEVE INSERTION IT WAS NOTICED THAT THE INSTRUMENTS IN QUESTION WERE STARTING TO FALL APART AT THE END. ALL WOOD CHIPS FROM THE HANDLES WERE REMOVED AND THROWN AWAY. INSTRUMENTS ARE BEING RETURNED. COULD NOT FIND A LOT NUMBER ON ONE OF THE INSTRUMENTS. NO SURGICAL DELAY WAS THERE.