MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/3H SHAFT/LEFT; PLATE, FIXATION, BONE

Model Number	02.210.114
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not been explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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 during a distal radius procedure on an unknown date, when the surgeon inserted a locking screw using a 1.8 threaded drill guide in the proximal portion in the shaft of a 2.4mm variable angle locking compression plate (va ¿ lcp) two column volar distal radius plate, the screw would not lock into the plate.Instead, they used a 2.4 cortical screw.There was no other medical intervention required.There was no patient consequence reported.There was a 5-minutes delay during the procedure.The procedure was successfully completed.Concomitant device(s): 1.8 threaded drill guide (part#: unknown; lot#: unknown; quantity: 1) this report is for a 2.4mm va-lcp 2-clmn vlr dstl radius pl 6h hd/3h shaft/left.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.Date of event : corrected to (b)(6) 2018 as it should have been reported in mwr-(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.

• Brand Name: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/3H SHAFT/LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7526545
• Report Number: 2939274-2018-52227
• Device Sequence Number: 1305149
• Product Code: HRS
• UDI-Device Identifier: 10886982052919
• UDI-Public: (01)10886982052919
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.210.114
• Device Catalogue Number: 02.111.631
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention