MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH QUICK COUPLING; MISC ORTHO SURGICAL INSTR

Model Number	03.111.038
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
Additional device product code: hxx.Complainant part is not expected to be returned for manufacturer review / investigation.Reporter is synthes sales consultant.A device history record (dhr) review was conducted: part: 03.111.038, lot: 2734804, manufacturing site: (b)(4), release to warehouse date: 17.May 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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 on an unknown date, during procedure, the scrub tech was putting the t8 screwdriver attachment onto the handle with quick coupling, the end cap fell off onto the floor.Surgery was successfully completed without delay by using the screwdriver without the endcap.There was no patient consequence.Concomitant device reported: stardrive screwdriver shaft t8 105 mm (part #: 314.467, lot # unknown, quantity # 1).This report is for one (1) handle with quick coupling.This is report 1 of 1 for complaint (b)(4).

• Brand Name: HANDLE WITH QUICK COUPLING
• 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: 9009681
• Report Number: 2939274-2019-60491
• Device Sequence Number: 16649856
• Product Code: LXH
• UDI-Device Identifier: 10886982072368
• UDI-Public: (01)10886982072368
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/14/2019

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: 03.111.038
• Device Catalogue Number: 03.111.038
• Device Lot Number: 2734804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1