CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 4 MM
Report
- Report Number
- 0009610622-2015-00400
- Event Type
- Malfunction
- Date Received
- August 19, 2015
- Date of Event
- June 15, 2015
- Report Date
- July 21, 2015
- Manufacturer
- STRYKER TRAUMA KIEL (MDR)
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
PRODUCT HAS BEEN RECEIVED AND EVALUATED. EVALUATION REVEALED BOTH RETURNED CONICAL EXTRACTORS (CAT # 18066170 AND 18066172) TO BE PRIMARY PRODUCTS. THIS INVESTIGATION IS RELATED TO THE CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACT. SET 2.5 MM (CAT # 18066170, LOT CODE K107085). REVIEW OF THE DHR REVEALED NO DISCREPANCIES AND MECHANICAL PROPERTIES OF THE MATERIAL OF THE DEVICE ARE WITHIN SPECIFIED TOLERANCES. THE CONICAL EXTRACTOR RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION AND AS IT HAD BEEN IN USE FOR A LONGER TIME (MANUFACTURED IN 2010) WE PRE-SUPPOSE THAT IT HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED WITHOUT PROBLEMS REPORTED. THUS, WE EXCLUDE DEVIATIONS IN MATERIAL AND MANUFACTURING. THE CONICAL EXTRACTOR IS DEVELOPED FOR IMPLANT (SCREW) EXTRACTION. IT IS USED AS THE LAST OPTION (¿EMERGENCY INSTRUMENT¿) IN CASE STANDARD INSTRUMENTS FAIL DURING EXPLANTATION. IT WAS REPORTED THAT BOTH INSTRUMENTS WERE USED IN ORDER TO REMOVE A GAMMA NAIL AND A MODIFIED LAG SCREW. BOTH INSTRUMENTS ARE NOT INTENDED FOR REMOVAL OF A GAMMA NAIL OR A (MODIFIED) LAG SCREW. THE INTENDED USE IS CLEARLY INDICATED IN THE BROCHURE ¿IMPLANT EXTRACTION SET / IMPLANT EXTRACTION GUIDE MODULE ONE & TWO¿. APPEARANCE OF THE BREAKAGE SURFACE AND THE OBLIQUE BREAKAGE LINE OF THE SUBJECT CONICAL EXTRACTOR INDICATE THAT THE DEVICE BROKE IN A (FORCED) BRITTLE MANNER DUE TO A COMBINATION OF TORSIONAL OVERLOAD AND HIGH BENDING STRESSES (USING THE ITEM AS A LEVER). THE INSTRUMENT IS LASER-MARKED WITH THE INFORMATION ¿DO NOT LEVER¿ IN ORDER TO PREVENT THIS KIND OF ISSUE. THE MATERIAL WAS HARDENED IN ORDER TO BE HARDER THAN THE SCREWS TO BE REMOVED. HARDENED MATERIALS ARE BRITTLE AND RATHER BREAK THAN BEND. BASED ON THE ABOVE THE ROOT CAUSE OF THE REPORTED EVENT IS NOT RELATED TO A DEFICIENCY OF THE DEVICE, BUT IS RATHER LINKED TO MISUSE BY THE USER. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. NO NON-CONFORMITY WAS IDENTIFIED.
IT WAS REPORTED THAT THREADED EXTRACTION PIECES WERE USED TO REMOVE END CAP. THREADED END BROKE OFF AND WAS DISCARDED DURING SURGERY. THIS WAS A GAMMA NAIL WHERE A SURGEON CUT OFF DISTAL END OF THE LAG DURING A PREVIOUS SURGERY. WE WERE USING EASYOUTS TO TRY AND BACK OUT LAG SCREW. THE GAMMA NAIL WAS LEFT IN SITE AS THEY COULDN'T BE REMOVED, BOTH STRYKER CONICAL EXTRACTORS WERE USED AND BOTH BROKE DURING ATTEMPTED REMOVAL. NO DEBRIS WAS LEFT AROUND SITE.
IT WAS REPORTED THAT THREADED EXTRACTION PIECES WERE USED TO REMOVE END CAP. THREADED END BROKE OFF AND WAS DISCARDED DURING SURGERY. THIS WAS A GAMMA NAIL WHERE A SURGEON CUT OFF DISTAL END OF THE LAG DURING A PREVIOUS SURGERY. WE WERE USING EASYOUTS TO TRY AND BACK OUT LAG SCREW. THE GAMMA NAIL WAS LEFT IN SITE AS THEY COULDN'T BE REMOVED, BOTH STRYKER CONICAL EXTRACTORS WERE USED AND BOTH BROKE DURING ATTEMPTED REMOVAL. NO DEBRIS WAS LEFT AROUND SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549591 | CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 4 MM | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | STRYKER TRAUMA KIEL (MDR) | K284976 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |