CMK OC - RASP S303
Report
- Report Number
- 3006946279-2025-00081
- Event Type
- Malfunction
- Date Received
- June 10, 2025
- Date of Event
- May 14, 2025
- Report Date
- January 27, 2026
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Product Code
- LZO
- UDI-DI
- 03599870033685
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H6, H11. COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. 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. THE PRODUCTS INVOLVED IN THE REPORTED EVENT WERE RETURNED FOR INVESTIGATION. ALL 10 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 DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.
(B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10: CMK OC - RASP S303; ITEM# 88-100-33000; LOT# 1921365070; QUANTITY- (B)(4). 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. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H11. 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H2, H3, H6, H10, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE RASP BROKE DURING INTERNAL TESTING. NO PATIENT INVOLVED, NO HARM TO THE OPERATOR. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1266123 | CMK OC - RASP S303 | HIP INSTRUMENT | LZO | BIOMET FRANCE S.A.R.L. | 1921365070 | 03599870033685 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | SEE H11 NARRATIVE. |