MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI VA-LCP VOLAR DISTAL RADIUS PLATE 5H HEAD/3H SHAFT/RT; PLATE, FIXATION, BONE

Model Number	04.110.201
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
Additional patient identifier: (b)(6).Implanted 3 months ago; exact date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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 a patient underwent a hardware removal of a titanium variable angle volar distal radius plate on an unknown date.The plate was proud distally, it was also at risk for flexor pollicis longus rupture.Fracture was healed, and all hardware was removed with no issues.The plate was put in three (3) months ago.It is unknown if there was surgical delay.Procedure outcome was successful.Patient status is unknown.Concomitant devices: 2.4mm ti cortex screw self-tapping 18mm (part # 401.518.96, lot # unknown quantity 1); 2.4mm ti va locking screw stardrive 18mm (part # 04.210.118, lot # unknown quantity 6).This report is for one (1) ti va-lcp volar distal radius plate.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part: 04.110.201; lot: h126456; part manufacture date: june 21, 2016; manufacturing location: elmira; part expiration date: n/a; nonconformance noted: n/a.A review of the device history record (dhr) revealed no complaint related anomalies.The device history record shows this lot of titanium (ti) va-lcp volar distal radius plate 5h head/3h shaft/rt product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Review of the raw material is required only for broken devices.This complaint was not initiated for a broken plate.Therefore, no raw material review was conducted for this dhr review.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
Removal procedure occurred on (b)(6) 2019.

• Brand Name: TI VA-LCP VOLAR DISTAL RADIUS PLATE 5H HEAD/3H 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: 8329541
• Report Number: 2939274-2019-56407
• Device Sequence Number: 10814651
• Product Code: HRS
• UDI-Device Identifier: 10886982100382
• UDI-Public: (01)10886982100382
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071184
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2019

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: 04.110.201
• Device Catalogue Number: 04.110.201
• Device Lot Number: H126456
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 03/06/2019; 03/14/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/14/2019; 03/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR