MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM CRUCIFORM SCRWDRVR BLADE W/SPRING HOLDING SLV-SHORT-HXC; SCREWDRIVERS

Model Number	314.675
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Event or Problem Description
It was reported that on (b)(6) 2019, the two (2) cruciform screwdriver blade with spring holding sleeve were stripped and not working properly during an unknown procedure.The procedure was successfully completed with no surgical delay.There was no patient consequence.This report is for one (1) 2.0mm cruciform screwdriver blade w/spring holding slv-short.This is report 2 of 2 for complaint (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 history record review: part: 314.675, lot: 9608353.Manufacturing site: hägendorf.Release to warehouse date: 02 october 2015 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary: visual inspection performed at customer quality (cq) observed that the driver is slightly stripped/deformed at the distal threaded tip which may hinder the device from functioning as intended.The balance of the device is in fair condition.A device failure was identified.An accurate dimensional analysis could not be performed due to the post manufacturing damage of the distal tip.Drawing(s) were reviewed with no findings the exact cause of the damaged threads is unknown, but it is likely due to wear from repeated use over the lifetime of the multiple use device.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 2.0MM CRUCIFORM SCRWDRVR BLADE W/SPRING HOLDING SLV-SHORT-HXC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8612886
• Report Number: 2939274-2019-58045
• Device Sequence Number: 11291432
• Product Code: HXX
• UDI-Device Identifier: 10887587037639
• UDI-Public: (01)10887587037639
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 314.675
• Device Catalogue Number: 314.675
• Device Lot Number: 9608353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR