MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC POSITIONING SCREW FOR DISTAL RADIUS GUIDE BLOCK

Model Number	03.111.007
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Without a lot number the device history records review could not be completed.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 surgeon was unable to screw the aiming block for distal radius plate onto the plate.The attempt was made using different plates.The surgeon suggested that the screw might be stripped.There was no patient involvement.Concomitant device: distal radius plate (part: unknown, lot: unknown, quantity: unknown).This report is for a positioning screw for distal radius guide block.This is report 2 of 2 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.H11 corrected data: b1, b5, h1: the initial complaint was reviewed and found not reportable.The screw is part of the guide block 03.111.701 assembly.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: POSITIONING SCREW FOR DISTAL RADIUS GUIDE BLOCK
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8391970
• Report Number: 2939274-2019-56823
• Device Sequence Number: 1783697
• Product Code: FZX
• UDI-Device Identifier: 10886982072085
• UDI-Public: (01)10886982072085
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 02/07/2019

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: 03.111.007
• Device Catalogue Number: 03.111.007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1