CMK OC - RASP S304
Report
- Report Number
- 3006946279-2025-00090
- Event Type
- Malfunction
- Date Received
- July 9, 2025
- Date of Event
- June 2, 2025
- Report Date
- February 2, 2026
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Product Code
- LZO
- UDI-DI
- 03599870033692
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
(B)(4). D4 - THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024132023. D10 - ASSOCIATED DEVICES: CMK OC - RASP S202; ITEM# 88-100-22000; LOT# 1921365030, CMK OC - RASP S202; ITEM# 88-100-22000; LOT# 1921365030, CMK OC - RASP S304; ITEM# 88-100-34000; LOT# 1921365080, CMK OC - RASP S304; ITEM# 88-100-34000; LOT# 1921365080, CMK OC - RASP S304; ITEM# 88-100-34000; LOT# 1921365080, CMK OC - RASP S304; ITEM# 88-100-34000; LOT# 1921365080, CMK OC - RASP S203; ITEM# 88-100-23000; LOT# 1921365040, CMK OC - RASP S203; ITEM# 88-100-23000; LOT# 1921365040. G2 - FOREIGN: JAPAN. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K192660. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H10, H11. THE PRODUCTS INVOLVED IN THE REPORTED EVENT WERE RETURNED FOR INVESTIGATION. ALL RASPS WERE RECEIVED WITHOUT THE HANDLE COMPONENTS, WHICH ARE TYPICALLY WELDED ONTO THE PROXIMAL FACE OF EACH RASP. NO HANDLE COMPONENTS WERE RETURNED FOR EVALUATION. PER DESIGN SPECIFICATIONS, ALL ZIMMER BIOMET (ZB) ETCHING IS APPLIED TO THE HANDLE COMPONENT. AS NO HANDLES WERE RETURNED, NO ZB ETCH CONTENT WAS AVAILABLE FOR VERIFICATION. THE PROXIMAL FACES OF ALL RETURNED RASPS SHOW EVIDENCE OF MODIFICATION, FEATURING CONSISTENT OR SIMILAR GEOMETRIC ALTERATIONS. THESE INCLUDE POSTS EXHIBITING VISUAL CHARACTERISTICS CONSISTENT WITH FRACTURED SURFACES. HOWEVER, NO FRACTURED POST FRAGMENTS WERE RETURNED FOR ANALYSIS. ADDITIONALLY, NON-ZB ETCH CONTENT WAS OBSERVED WITHIN THE MODIFIED REGION OF THE PROXIMAL END ON ALL RETURNED RASPS. BASED ON VISUAL INSPECTION, THE RETURNED RASPS DO NOT CONFORM DUE TO THE ALTERED PROXIMAL ENDS. DIMENSIONAL VERIFICATION WAS NOT PERFORMED BECAUSE THE DEVICES ARE IN A MODIFIED STATE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. IFU HAS BEEN REVIEWED AND STATED THAT "DO NOT POLISH OR MODIFY". REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION/S. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. BASED ON THE TECHNICAL EVALUATION, IT CAN BE CONCLUDED THAT THE PRODUCTS HAVE BEEN REPROCESSED AND MODIFIED. IT IS LIKELY THAT THE MODIFICATION CONTRIBUTED TO THE FRACTURE. HOWEVER, IF AND TO WHAT EXTEND OTHER FACTORS MAY HAVE PLAYED A ROLE REMAINS UNKNOWN. THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE REMAINS UNKNOWN. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT AND MEDWATCH REPORT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 3002806535. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT THE RASP BROKE DURING INTERNAL TESTING. NO PATIENT INVOLVED, NO HARM TO THE OPERATOR. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT AND MEDWATCH REPORT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 3002806535.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451160 | CMK OC - RASP S304 | HIP INSTRUMENT | LZO | BIOMET FRANCE S.A.R.L. | 1921365080 | 03599870033692 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |