ADAPT Ø2.8 F/LCP PAED-HIP PL3.5/5.0
Received Feb 22, 2013 · Event occurred Jan 14, 2013
Report 8030965-2013-00611 · MDR key 2974840
Device
Product problems
- Naturally Worn
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.
Description of Event or Problem
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SHAFT OF THE K-WIRE ADAPTOR USED IN PROCEDURES PREVIOUSLY, WAS WORN AND EXHIBITED GROOVES. IT WAS REPORTED THE ADAPTOR WAS USED APPROXIMATELY 10 TIMES. THIS IS 1 OF 1 REPORT.
Additional Manufacturer Narrative
DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE ADAPTER WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. WE FOUND THAT AROUND ON THE ADAPTER SHAFT ARE BADLY DAMAGED AND SHOW CLEARLY VISIBLE STRESS MARKS. THE EXCESSIVE DAMAGE TO THE SHAFT INDICATES THAT THE RECEPTACLES OF THE ADAPTER WAS ON THE WHOLE SHAFT AND WAS NOT AT THE DESIGNATED THREE INTERFACE COUPLING END. NO PRODUCT FAULT COULD BE DETECTED.