MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 7H HD/3H SHAFT/RIGHT; PLATE,FIXATION,BONE

Catalog Number	02.111.730
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device malfunctioned intraoperative.Device was not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review is pending completion.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 the patient underwent an open reduction internal fixation (orif) due to a distal radius fracture on (b)(6) 2018.During the surgery while the variable angle (va) locking compression plate (lcp) two column distal radius plate was being used, two different distal locking holes in the head of the plate did not lock.It was reported that the plate which did not lock was not implanted.The surgeon tried several times to make it work, but had to pull it out and used another plate.There was a thirty (30) minutes surgical delay reported.The fracture of the patient was fixed appropriately.The procedure was completed successfully with no harm to the patient.This report is for one (1) 2.4mm va-lcp 2-clmn vlr dstl radius pl 7h hd/3h shaft/right.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Corrected data: udi.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
Concomitant device reported: non-locking screw (part number unknown, lot number unknown, quantity 1).
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 is not expected to be returned for manufacturer review/investigation.Device history records review was completed for part# 02.111.730, lot# 3226525.Manufacturing location: mezzovico, release to warehouse date: aug 14, 2009.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 7H HD/3H SHAFT/RIGHT
• 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: 7491375
• Report Number: 2939274-2018-52052
• Device Sequence Number: 19258612
• Product Code: HRS
• UDI-Device Identifier: 10886982072542
• UDI-Public: (01)10886982072542
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 04/16/2018

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 Catalogue Number: 02.111.730
• Device Lot Number: 3226525
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 05/09/2018; 06/08/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 05/24/2018; 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR