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

Model Number	351.15
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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).

• Brand Name: FLEXIBLE SHAFT HANDLE WITH QUICK COUPLING
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8894901
• Report Number: 2939274-2019-59825
• Device Sequence Number: 13863642
• Product Code: HTO
• UDI-Device Identifier: 10886982193728
• UDI-Public: (01)10886982193728
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 351.15
• Device Catalogue Number: 351.15
• Device Lot Number: 2285661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1