MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE WITH LOCKING DEVICE; SCREWDRIVERS

Model Number	03.010.112
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is synthes employee.A product investigation was conducted.Visual inspection:the holding sleeve with locking device (p/n: 03.010.112, lot number: l884756) was received at us cq.Upon visual inspection, the captivation nut and coupling sleeve components are missing.Document/specification review: relevant document was reviewed.No design issues or discrepancies were identified.Dimensional inspection: a dimensional inspection was not performed due to the definitive finding of missing components.Conclusion: the overall complaint was confirmed for the holding sleeve with locking device (p/n: 03.010.112, lot number: l884756) as the captivation nut and coupling sleeve components are missing.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.A device history record (dhr) review was conducted: part: 03.010.112.Lot: l884756.Manufacturing site: hägendorf.Release to warehouse date: 22 june 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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 an unknown date, during routine incoming inspection of loaner set it was observed that the holding sleeve with locking device was missing a part.There was no patient involvement.This is report 1 of 1 for complaint (b)(4).

• Brand Name: HOLDING SLEEVE WITH LOCKING DEVICE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9941583
• Report Number: 2939274-2020-01780
• Device Sequence Number: 14017225
• Product Code: HXX
• UDI-Device Identifier: 10886982067845
• UDI-Public: (01)10886982067845
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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: 03.010.112
• Device Catalogue Number: 03.010.112
• Device Lot Number: L884756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1