HANDLE WITH MINI QUICK COUPLING

Report

Report Number: 2939274-2019-56392
Event Type: Malfunction
Date Received: February 11, 2019
Report Date: January 22, 2019
Manufacturer: WRIGHTS LANE SYNTHES USA PRODUCTS LLC
Product Code: HWX
UDI-DI: 10886982187192
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: D10: THE DEVICE WAS RECEIVED. H3, H4, H6: DEVICE HISTORY LOT: PART NUMBER: 311.01. SYNTHES LOT NUMBER: 9850715. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: 13-JUL-2015. EXPIRATION DATE: N/A. MANUFACTURED BY SYNTHES JENNERSVILLE. NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: INVESTIGATION SUMMARY: BACKGROUND: IT WAS REPORTED THAT THE SCREWDRIVER HANDLE WITH MINI QUICK COUPLING BROKE OFF. IT IS UNKNOWN IF WHEN WAS THE ISSUE DISCOVERED. IT IS UNKNOWN IF THERE WAS A PATIENT OR PROCEDURE INVOLVEMENT. SERVICE EVALUATION: THE CUSTOMER REPORTED THE DEVICE WAS FOUND BROKEN. THE REPAIR TECHNICIAN REPORTED THE DEVICE WAS DAMAGED. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WAS SCRAPPED AND WAS FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. SERVICE HISTORY: NO SERVICE HISTORY REVIEW WAS POSSIBLE AS THE DEVICE IS LOT/BATCH CONTROLLED. DEVICE EVALUATION: INVESTIGATION FLOW: FUNCTIONAL. VISUAL INSPECTION: THE DEVICE (PART 311.01, LOT 9850715) WAS RETURNED TO US CUSTOMER QUALITY FOR FURTHER INVESTIGATION. UPON VISUAL INSPECTION, THE DISTAL COUPLING MECHANISM WAS STUCK IN THE RETRACTED POSITION AND IT WOULD NOT FULLY OPEN AND CLOSE. THE BALANCE OF THE DEVICE SHOWS SURFACE WEAR CONSISTENT WITH USE AND WHICH WOULD NOT IMPACT THE FUNCTIONALITY. THE COMPLAINT CONDITION IS CONFIRMED. FUNCTIONAL TESTING: FUNCTIONAL TESTING COULD NOT BE PERFORMED WITH THE MATING SCREWDRIVER AS IT WAS NOT RETURNED FOR EVALUATION. HOWEVER, FUNCTIONAL TESTING OF THE COUPLING MECHANISM IS JAMMED. THE MECHANISM COULD NOT BE RELEASED FROM THE RETRACTED POSITION. IN THE ADVANCED STATE THE MECHANISM LOCKS ONTO THE MATING SCREWDRIVER AND IN THE RETRACTED STATE THE MECHANISM RELEASES THE MATING SCREWDRIVER. THUS, IN THIS RETRACTED POSITION, THE DEVICE WOULD NOT BE EXPECTED TO RETAIN THE MATING SCREWDRIVER. DOCUMENT REVIEW: RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED: TOP LEVEL ASSEMBLY DRAWING FOR: MINI QUICK COUPLING 311.01 REVISION U/Y (MANUFACTURED/CURRENT VERSION). BASED ON THE REVIEW OF THE ABOVE DRAWINGS, NO DESIGN ISSUES CONTRIBUTING TO RELEVANT COMPLAINT CONDITION WERE IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DIMENSIONAL INSPECTION: THE ONLY DIMENSION RELEVANT TO THE COMPLAINT CONDITION THAT WAS ABLE TO BE TESTED AT US CQ WAS THE DIAMETER OF THE CANNULATION IN THE COUPLING. DAMAGE TO INTERNAL COMPONENTS COULD HAVE CONTRIBUTED TO COMPLAINT CONDITION. A DIMENSIONAL ANALYSIS TO MEASURE SHAFT DIAMETER OF ALIGNMENT PLUG COULD NOT BE PERFORMED AS THE PRODUCT COULD NOT BE DISASSEMBLED. CONCLUSION: THE COMPLAINT CONDITION OF IS CONFIRMED. NO NEW ISSUES WERE IDENTIFIED ON THE REMAINING PORTIONS OF THE DEVICE. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITELY DETERMINED GIVEN THE UNKNOWN CIRCUMSTANCES, IT IS PROBABLE THAT AN UNINTENDED FORCES DURING USAGE/ HANDLING SUCH AS DROPPING OFF THE FLOOR EXCESSIVE LOADING AND/OR ROUGH HANDLING OVER 4+ YEARS IN THE FIELD CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. D4: LOT NUMBER. 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.

Additional Manufacturer Narrative · 1

COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE MAINTENANCE, THE HANDLE WITH MINI QUICK COUPLING WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
119371	HANDLE WITH MINI QUICK COUPLING	TAP,BONE	HWX	WRIGHTS LANE SYNTHES USA PRODUCTS LLC	311.01	9850715	10886982187192

Patients

Seq	Age	Sex	Outcome	Treatment
1