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

Model Number 04.111.621

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Rupture (2208)

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

It was reported that a distal radius plate was removed on (b)(6) 2019.According to the surgeon, the plate was placed too distally which caused a tendon to rupture over time.Two (2) of the 2.4 variable angle (va) locking screw broke during removal, but fragments were removed successfully.A tendon repair was then performed.The original surgery was done in richardson, texas about five (5) years ago.The plate and screws were successfully removed.Patient outcome is unknown.Concomitant devices: locking screws (part: unknown, lot: unknown, quantity: 4), cortex screws (part: unknown, lot: unknown, quantity: 2).This report is for a titanium (ti) variable-angle locking compression plate (va-lcp).This is report 1 of 1 for (b)(4) and captures the postoperative tendon rupture.The breakage of screws during removal is captured under related (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.Part: 04.111.621; lot: 9775993; manufacturing site: mezzovico; release to warehouse date: december 22, 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

• Brand Name: 2.4MM TI VA-LCP 2-CLMN VLR DST RADIUS PL 6H HD/2H SHAFT/LT
• 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: 8469484
• MDR Text Key: 140479987
• Report Number: 2939274-2019-57201
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982101808
• UDI-Public: (01)10886982101808
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

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
• Device Operator: Health Professional
• Device Model Number: 04.111.621
• Device Catalogue Number: 04.111.621
• Device Lot Number: 9775993
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 04/22/2019
• Supplement Dates FDA Received: 04/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention