CURVED THIN HOOK 17IN W/ DISK
Received Dec 21, 2022 · Event occurred Dec 12, 2022
Report 1818910-2022-25924 · MDR key 16023608
Device
Generic name
Hip Instruments : Hooks
Manufacturer
Depuy Orthopaedics Inc UsModel number
6020-12-000Catalog number
602012000
Lot number
BG0915
Product problems
- Break
- Break
Patient
61 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 SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: ADDED: D9 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CORRECTED: H3.
Additional Manufacturer Narrative
PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE TIP OF THE DEVICE BROKEN OFF. THE BROKEN PART WAS NOT RETURNED. THE REPORTED CONDITION WAS CONFIRMED. ADDITIONAL MONITORING, FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED, AS NO LOT NUMBER WAS PROVIDED FOR THIS DEVICE.
Description of Event or Problem
IT WAS REPORTED THAT WHILE REMOVING CEMENT DURING A KNEE REVISION THE DISTAL END OF THE INSTRUMENT BROKE OFF. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT BUT THE SCRUB NURSE THREW IT AWAY SO IT WILL NOT BE RETURNED WITH THE REST OF THE INSTRUMENT. THERE WAS NO SURGICAL DELAY.
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.