MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SMALL UNIVERSAL CHUCK WITH T-HANDLE; MISC ORTHO SURGICAL INSTR

Model Number	393.105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 a routine incoming inspection of a loaner set on an unknown date, the small universal chuck with t-handle was observed broken.There were no patient and surgical involvement.This report is for 1 small universal chuck with t-handle.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
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.Part: 393.105, lot: 8335350, manufacturing site: hägndorf, release to warehouse date: may 31, 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the small universal chuck with t-handle (p/n: 393.105, lot #: 8335350) was returned and received at us customer quality (cq).Upon visual inspection, there were scratches and nicks all over the device but have no impact on the device functionality.The tips of the clamps were nicked and deformed.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review based on the date of manufacture the following drawings: the current and manufactured revision of drawings were reviewed.Complaint confirmed? no.Investigation conclusion the complaint condition was not confirmed for the small universal chuck with t-handle (p/n: 393.105, lot #: 8335350).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause for the deformation could be due to unintended forces applied to the device.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.

• Brand Name: SMALL UNIVERSAL CHUCK WITH T-HANDLE
• 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: 10225919
• Report Number: 2939274-2020-03075
• Device Sequence Number: 19657863
• Product Code: LXH
• UDI-Device Identifier: 10886982199034
• UDI-Public: (01)10886982199034
• 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,Followup
• Report Date (Section B): 06/22/2020

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: 393.105
• Device Catalogue Number: 393.105
• Device Lot Number: 8335350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1