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

Catalog Number 02.111.720

Device Problem Device-Device Incompatibility (2919)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

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.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 Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the locking screw was not blocked on the plate for radar palm distance on the top of the radial column of the plate.It was redirected using the variable angle guide but the result was always the same.For this reason, it was decided to withdraw it.This report is for one (1) 2.4mm va-lcp 2-clmn vlr dstl radius pl 7h hd/2h shaft/right.This is report 2 of 2 for (b)(4).

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.H3, h4, h6- 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 history lot part: 02.111.720, lot: 5l97437, manufacturing site: raron, release to warehouse date: 06.September 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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/2H SHAFT/RIGHT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10800826
• MDR Text Key: 215036150
• Report Number: 2939274-2020-04988
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K083694
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.111.720
• Device Lot Number: 5L97437
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention