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
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 involves one (1) small universal chuck with t-handle.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
H11 (corrected data): b1, b5, h1: the initial complaint was reviewed and found not reportable.This complaint is a duplicate of report (b)(4).

• 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: 10199684
• Report Number: 2939274-2020-02991
• Device Sequence Number: 1071660
• 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): 06/15/2020

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: 8335359
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1