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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING REAMER

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING REAMER Back to Search Results
Model Number 351.15
Device Problem Device-Device Incompatibility
Event Type  Malfunction  
Manufacturer Narrative

Part: 351. 150; lot: 2285661; manufacturing site: bettlach; release to warehouse date: august 07, 2007. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. Visual inspection: the flexible shaft handle with quick coupling was received with both internal pins missing from the quick coupling. No other visual issues were identified with the returned components of the device. Functional inspection: functional testing could not be completed as mating devices were not received. However, the missing internal pins causes the device to be unable to couple/assemble with mating devices. The reported complaint condition could not be replicated as mating devices were not received. The device failure/defect of missing components was identified during the investigation and is related to the reported complaint condition. Dimensional inspection: dimensional inspection was not conducted as the visual issue of missing components is conclusive. Document/specification review: the following drawings, reflecting the manufactured and current revision, were reviewed. Handgriff mit schnellkupplung. Handgriff mit schnellkupplung. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. Conclusion: the complaint condition is confirmed for the flexible shaft handle with quick coupling as both internal pins were missing from the quick coupling. The missing internal pins causes the device to be unable to couple/assemble with mating devices. While no definitive root cause could be determined, it is possible that the device encountered unintended forces and/or rough handling, causing the pins to fall out and be misplaced. During this investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, 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.

 
Event Description

It was reported that during an intramedullary femur rod procedure on (b)(6) 2019, it was noticed that the flexible shaft handle with quick coupling attachment for reamer would not attach. Upon further examination, the inner of the device metal pin is missing. Procedure was successfully completed with no surgical delay. Patient outcome is unknown. This report is for a flexible shaft handle with quick coupling. This is report 1 of 1 for (b)(4).

 
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Brand NameFLEXIBLE SHAFT HANDLE WITH QUICK COUPLING
Type of DeviceREAMER
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ  2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key8894901
Report Number2939274-2019-59825
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number351.15
Device Catalogue Number351.15
Device LOT Number2285661
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/01/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/07/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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