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 Codes	Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: synthes rep.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 conclusion could be drawn at the time of filing this report.Investigation summary 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 (b)(6) 2019, during unknown intra-operation surgery, the shaft for 90 degree screwdriver would not put in screw into the patient and it kept stripping out.The procedure was successfully completed with a delay of 5 minutes using a new set of different screwdrivers.Patient status was unknown.This complaint involves ten (10) devices.This report is for one (1) 90 degree screwdriver t-handle.This report is 4 of 10 for (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.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.It was reported that on (b)(6)2019, during unknown intra-operation surgery, the shaft for 90 degree screwdriver would not put in screw into the patient and it kept stripping out.The procedure was successfully completed with a delay of 5 minutes using a new set of different screwdrivers.Patient status was unknown.It was reported that there was an allegation on the handle for 90° screwdriver as this was part of the entire device.It was reported that there was an allegation on the matrixrib screwdriver blade self-retaining f/90° scrwdrvr as this was part of the entire device.It was reported that there was an allegation on the 90 degree screwdriver t-handle as this was part of the entire device.It was reported that there was no allegation on the screw.It was reported that the screw would not turn due to the device of the 90 degree screwdriver.It was reported that no screws were stripped.It was reported that the screwdriver was not seating the screws into the plate.Concomitant device reported: unk - plates: trauma (part # unknown, lot # unknown, quantity # unknown).This complaint involves thirteen (13) devices.
Event or Problem Description
It was further reported that no screws were stripped, the screwdriver was not seating the screws into the plate.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: 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: 8908411
• Report Number: 2939274-2019-59927
• Device Sequence Number: 19432326
• Product Code: HWE
• UDI-Device Identifier: 10887587071671
• UDI-Public: (01)10887587071671
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 07/23/2019

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: SD03.505.005
• Device Catalogue Number: SD03.505.005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/21/2019; 08/21/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/18/2019; 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1