MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH HEX COUPLING; BIT, DRILL

Model Number	03.120.005
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: synthes sales rep.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2019, during hand surgery, a screwdriver handle was not connecting to the screwdriver shaft and a depth gauge with a bent tip.There were few different shafts tried but was unsuccessful in getting a connection.There was no surgical delay.Procedure outcome was successfully completed.The patient was not affected.Concomitant device: unknown screwdriver shaft (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) devices.This report is 1 of 1 for (b)(4).

• Brand Name: HANDLE WITH HEX COUPLING
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8493770
• Report Number: 2939274-2019-57379
• Device Sequence Number: 16633095
• Product Code: HTW
• UDI-Device Identifier: 10886982074034
• UDI-Public: (01)10886982074034
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/15/2019

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: 03.120.005
• Device Catalogue Number: 03.130.005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/08/2019
• Patient Sequence Number: 1