MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/5H SHAFT/RIGHT; PLATE, FIXATION, BONE

Model Number	02.111.650
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(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.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient underwent a hardware removal surgery due the variable angle lcp plate that was bent.Originally, the patient was originally implanted with a variable angle locking compression plate (lcp) distal radius system on an unknown date.However, on unknown date, the patient fell wherein the patient's wrist was bent dorsally at about 45 degrees accompanied with pain.The implants were successfully explanted and was revised with the same plate.The procedure was completed successfully without surgical delay.Concomitant device reported: unknown screws ( part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) 2.4 mm va-lcp 2-clmn vlr dstl radius pl 6h hd / 5h shaft / right.This is 1 of 1 for report (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.H10 additional narrative: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the images provided in attachments ¿4a74f9f9-eec2-42e5-969b-bb6fdb32d97f.Jpeg,¿ ¿bff23ecd-298d-4164-95f9-e8c5fda69222.Jpeg,¿ ¿4a74f9f9-eec2-42e5-969b-bb6fdb32d97f.Jpeg,¿ and ¿865efb57-a619-489d-a62a-aa643946347e.Jpeg.¿ the images were reviewed, and the complaint condition is confirmed as the image depicts a 2.4mm va-lcp 2-clmn vlr dstl radius pl 6h hd/5h shaft/right that is deformed/bent.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation was not performed since no lot number was provided.Furthermore, the device condition displays no evidence supporting a relationship between its condition and a manufacturing-related potential cause.Since no manufacturing-related potential cause is suspected, a manufacturing record evaluation is not required per franchise complaint product investigation procedure 100673626.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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/5H 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: 9256917
• Report Number: 2939274-2019-61833
• Device Sequence Number: 2599808
• Product Code: HRS
• UDI-Device Identifier: 10886982032072
• UDI-Public: (01)10886982032072
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K083694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02.111.650
• Device Catalogue Number: 02.111.650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 10/31/2019
• Patient Sequence Number: 1