2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 20MM
Report
- Report Number
- 8030965-2018-50113
- Event Type
- Malfunction
- Date Received
- January 5, 2018
- Date of Event
- December 5, 2017
- Report Date
- December 6, 2017
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HWC
- PMA / PMN Number
- K103243
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. POTENTIAL PART AND LOT NUMBERS OF THE SCREWS ARE REPORTED AS BELOW; HOWEVER IT IS UNKNOWN WHICH SCREW BROKE FROM THE FOLLOWING LISTED SCREWS. WITHOUT THE SPECIFIC PART AND LOT NUMBERS, THE UDI NUMBER IS UNKNOWN. 2.4MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM (PART # 401.764S, LOT # L097242). 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 14MM (PART # 412.814S, LOT # L283356). 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 16MM (PART # 412.816S, LOT # 9769107). 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 16MM (PART # 412.816S, LOT # 9861744). 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 16MM (PART # 412.816S, LOT # 9964290). 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM (PART # 412.818S, LOT # 9910920). 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 20MM (PART # 412.820S, LOT # 9740006). UNKNOWN. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (510K#): UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.
A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NUMBER: 412.820S, SYNTHES LOT NUMBER: 9740006, RELEASE TO WAREHOUSE DATE: 27.NOV.2017. EXPIRY DATE: 01.NOV.2027, MANUFACTURING SITE: (B)(4). NONCONFORMANCE WAS ISSUED. PLEASE REVIEW THE DHR AND PROVIDE A STATEMENT IF THIS NONCONFORMANCE (NC) DOES HAVE A CONNECTION TO THIS COMPLAINT OR NOT. THE REVIEW OF THE NR WAS PERFORMED AND SHOWS THAT THE ISSUE IS RELATED TO "BURRS". THEREFORE, IS NOT RELATED TO THE COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: WE HAVE RECEIVED THE CORTEX SCREW BROKEN IN TO TWO PIECES. THE SCREW IS BROKEN CLOSE TO THE SCREW HEAD AS COMPLAINED. THE THREADED SHAFT IS STRONGLY DAMAGED AND SLIGHTLY BENT. THE STARDRIVE ON THE HEAD OTHERWISE IS STILL IN GOOD CONDITION. THE STRONG DAMAGES AT THE THREAD WERE MOST PROBABLY CAUSED DURING REMOVAL WITH THE EXTRACTION BOLT. BECAUSE OF THE DAMAGE THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS ANYMORE. LOT 9740006 WAS MANUFACTURED IN NOVEMBER 2017, 40 PARTS ACCORDING TO OUR SPECIFICATIONS. ALL DEVICES WERE SOLD MEANWHILE AND WE ARE NOT AWARE OF ANY QUALITY ISSUES ASSOCIATED WITH THIS ARTICLE- AND LOT NUMBER. AFTERWARDS AND WITHOUT HAVING THE REPORTED EXTRACTION BOLT BACK, IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE COMPLAINED ISSUE. NOT EXACTLY FOLLOWING THE SURGICAL TECHNIQUE, OR A MECHANICAL OVERLOADING (LATERAL STRESS), ARE POSSIBLY CAUSES FOR THIS OCCURRENCE. BASED ON THESE FINDINGS, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.
THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. CORRECTED DATA: 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SCREW BROKE INTRA-OPERATIVELY, DURING A SCHEDULED REMOVAL SURGERY ON (B)(6) 2017. WHEN THE SURGEON REMOVED THE SCREW USING THE EXTRACTION BOLT THE SCREW BROKE. THE SURGEON COMMENTED THAT IT WAS DIFFICULT TO REMOVE THE SCREW USING THE EXTRACTION BOLT. IT IS UNKNOWN IF THE BROKEN PIECE OF THE SCREW WAS LEFT INSIDE THE PATIENT OR RETRIEVED. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY AND WITHOUT ANY OTHER MEDICAL INTERVENTION REQUIRED. PATIENT OUTCOME REPORTED AS OKAY. NO ADDITIONAL INFORMATION ON SURGICAL OPERATION HAS BEEN PROVIDED FROM THE HOSPITAL. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
CONCOMITANT DEVICES REPORTED: 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/3H SHAFT/LT-STER (PART # 04.111.631S, LOT # L215008, QUANTITY 1), 2.4MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM (PART # 401.764S, LOT # L097242, QUANTITY 1), 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 14MM (PART # 412.814S, LOT # L283356, QUANTITY 2), 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 16MM (PART # 412.816S, LOT # 9769107, QUANTITY 1), 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 16MM (PART # 412.816S, LOT # 9861744, QUANTITY 1), 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 16MM (PART # 412.816S, LOT # 9964290, QUANTITY 1), 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM (PART # 412.818S, LOT # 9910920, QUANTITY 1), 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 20MM (PART # 412.820S, LOT # 9740006, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 20MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12672 | 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 20MM | SCREW, FIXATION, BONE | HWC | OBERDORF SYNTHES PRODUKTIONS GMBH | 9740006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |