PELVIC OSTEOTOME 15MM/304MM
Report
- Report Number
- 8030965-2018-50240
- Event Type
- Injury
- Date Received
- January 10, 2018
- Date of Event
- December 7, 2017
- Report Date
- December 14, 2017
- Manufacturer
- OBERDORF : SYNTHES PRODUKTIONS GMBH
- Product Code
- HWM
- UDI-DI
- 07611819028081
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 399.850, LOT# 5911893. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: JUL 20, 2011. NO NON- CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE VISUAL INSPECTION OF THE RETURNED PELVIC OSTEOTOMY CHISEL HAS SHOWN THAT THE TIP SECTION IS COMPLETELY BROKEN OFF. IT WAS REPORTED THAT THE END OF THE CHISEL IS STILL IN THE PATIENT AS THE REMOVAL IS TOO RISKY. ADDITIONALLY, THERE WERE DAMAGES ON THE HANDLE DETECTED. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN JULY 2011 ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. THE MEASUREMENT OF THE HARDNESS DURING MANUFACTURING OF THE PRODUCTS HAS MET THE SPECIFICATION. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. UNFORTUNATELY, THE EXACT CAUSE WHICH HAS LED TO THE BREAKAGE COULD NOT BE DETERMINED. THE WEAR AND TEAR APPEARANCE OF THE INSTRUMENT IS AN INDICATION, THAT THE PRODUCT WAS USED IN AN EXCESSIVE WAY OVER THE YEARS, AS THE PRODUCT WAS MANUFACTURED JULY 2011. THE CAUSE OF THE DAMAGES COULD BE THE RESULT OF A MECHANICAL OVERLOAD SITUATION DURING USE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THESE DATES WERE INCORRECTLY REPORTED AS (B)(6) 2018 IN INITIAL REPORT (B)(4). THE CORRECT DATE IS (B)(6) 2018 DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DEVICE WAS NOT REPROCESSED INITIAL REPORTER POSTAL CODE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
(B)(4) WAS SUBMITTED WITHOUT A DATE IN THIS FIELD. DATE SHOULD HAVE BEEN 3/9/2018 DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PERIACETABULAR OSTEOTOMY WAS PERFORMED. DURING SURGERY THE PELVIC OSTEOTOMY CHISEL BROKE WHILE STARTING ISCHIAL OSTEOTOMY. THE END OF THE CHISEL IS STILL IN THE PATIENT AS THE REMOVAL IS TOO RISKY. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23807 | PELVIC OSTEOTOME 15MM/304MM | OSTEOTOME | HWM | OBERDORF : SYNTHES PRODUKTIONS GMBH | 5911893 | 07611819028081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Required Intervention |