MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/4H SHAFT/LEFT; PLATE, FIXATION, BONE

Model Number	02.111.641
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's information is unknown.Date of event: it is unknown when patient¿s pain began.Date of implantation is an unknown date in (b)(6) 2018.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review has been requested.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 in (b)(6) 2018, the patient was implanted with hardware.On an unknown postoperative date, the patient stated that she could feel the plate.During the hardware removal surgery on (b)(6) 2018, the surgeon removed the variable angle locking compression plate (va-lcp) two-column volar distal radius plates, unknown locking screws and unknown cortex screws due to pain.There were no issues during the hardware removal, all the implants came out.The surgery was completed successfully with good patient outcome.This report is for a 2.4mm va-lcp 2-column volar distal radius plate 6-hole head/4-hole shaft/left.This is report 1 of 3 for (b)(4).

• Brand Name: 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/4H 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: 7906442
• Report Number: 2939274-2018-53947
• Device Sequence Number: 11176075
• Product Code: HRS
• UDI-Device Identifier: 10886982032058
• UDI-Public: (01)10886982032058
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.111.641
• Device Catalogue Number: 02.111.641
• Device Lot Number: 3663974
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/25/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR