MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 16MM CANNULATED HOLLOW DRILL BIT; MISC ORTHO SURGICAL INSTR

Model Number	03.037.004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part number: 03.037.004.Synthes lot number: 150551-104.Manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: 03.May 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: visual inspection identified that the nitinol spring component on the centering attachment sub-assembly is missing.The weld that secured the spring to the body has failed.The complaint is confirmed.There were scratches consistent with device use and the etch on the device started to fade but has no effect on the functionality of the device.Document/specification review: hollow reamer assembly drawing.Centering attachment sub-assembly drawing.Centering attachment body component drawing.Nitinol spring component drawing.No product design issues or discrepancies were observed during this investigation.Dimensional inspection: a relevant dimensional inspection is not possible for the conditions of a failed weld and missing spring.Investigation conclusion: a definitive root cause for the missing spring could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 on (b)(6) 2020 the locking clip on the 16mm hollow reamer was missing the retention pin on the locking clip.This was noted by sterile processing personnel during set assembly.There was no patient involvement.This report is for one (1) 16mm cannulated hollow drill bit.This is report 1 of 1 for (b)(4).

• Brand Name: 16MM CANNULATED HOLLOW DRILL BIT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10220650
• Report Number: 2939274-2020-03055
• Device Sequence Number: 11416495
• Product Code: LXH
• UDI-Device Identifier: 10886982070203
• UDI-Public: 10886982070203
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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: 03.037.004
• Device Catalogue Number: 03.037.004
• Device Lot Number: 150551-104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1