MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA-LCP VOLAR RIM DISTAL RADIUS PLATE/7H HD/5H SHAFT/RT; PLATE,FIXATION,BONE

Model Number	02.115.850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id and weight were not provided for reporting.Date of event is unknown.Additional device code: hwc.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 an unknown date, patient was implanted with one (1) 2.4mm variable angle-locking compression plate (va-lcp) volar rim distal radius plate, six (6) 2.4mm variable angle (va) locking screws and three (3) 2.7mm cortex screws.On (b)(6) 2018 patient underwent removal surgery because as per the surgeon, the plate was placed too distal and was worried that it would cause patient issues.The hardware was removed successfully.Patient outcome was reported as good.This report is for one (1) 2.4mm va-lcp volar rim distal radius plate/7h hd/5h shaft/rt.This is report 1 of 3 for (b)(4).

• Brand Name: 2.4MM VA-LCP VOLAR RIM DISTAL RADIUS PLATE/7H HD/5H SHAFT/RT
• 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: 7637408
• Report Number: 2939274-2018-52626
• Device Sequence Number: 19461087
• Product Code: HRS
• UDI-Device Identifier: 10886982035585
• UDI-Public: (01)10886982035585
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.115.850
• Device Catalogue Number: 02.115.850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR