MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 90 DEGREE SCREWDRIVER T-HANDLE; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Model Number	SD03.505.005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
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.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 a rib fixation procedure, the 90-degree screwdriver would not work when inserting an unknown screw.The procedure was completed successfully, and the surgeon used a different unknown screwdrivers.There was a surgical delay five (5) minutes and there was no patient consequence reported.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).This complaint involves six (6) devices.This is report 3 of 6 for (b)(4).

• Brand Name: 90 DEGREE SCREWDRIVER T-HANDLE
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9922104
• Report Number: 2939274-2020-01707
• Device Sequence Number: 11595521
• Product Code: HWE
• UDI-Device Identifier: 10887587071671
• UDI-Public: (01)10887587071671
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: SD03.505.005
• Device Catalogue Number: SD03.505.005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1