PF*2 MOD TB CEM PUN SZ 4-5
Received Feb 27, 2025 · Event occurred Feb 11, 2025
Report 1818910-2025-03177 · MDR key 21481248
Device
Product problems
- Crack
- Device-Device Incompatibility
- Material Deformation
- Unintended Movement
- Crack
- Device-Device Incompatibility
- Material Deformation
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # :(B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT ==> THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A¿DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.¿ IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.
Description of Event or Problem
IT WAS REPORTED THAT THE FASTENING ON THE ITEM WAS FOUND LOOSE. THERE WAS AN ISSUE AT THE TOP WHERE IT CONNECTS TO THE HANDLE, A CRACK OR BEND. THE HANDLE WOULD NO LONGER CONNECT. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.
Additional Manufacturer Narrative
PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative
THE DEVICE MALFUNCTION, FUNCTIONAL : LOOSE WILL NO LONGER BE REPORTED AS THERE HAS NOT BEEN A SERIOUS INJURY ASSOCIATED WITH THIS FAILURE WITHIN THE PAST 2 YEARS. PLEASE CONSIDER THIS THE LAST MANUFACTURER REPORT NUMBER SUBMITTED AGAINST THIS MALFUNCTION.
Additional Manufacturer Narrative
THE DEVICE MALFUNCTION, VISUAL : DEFORMED/BENT, WILL NO LONGER BE REPORTED AS THERE HAS NOT BEEN A SERIOUS INJURY ASSOCIATED WITH THIS FAILURE WITHIN THE PAST 2 YEARS. PLEASE CONSIDER THIS THE LAST MANUFACTURER REPORT NUMBER SUBMITTED AGAINST THIS MALFUNCTION.