MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/4H/87MM/RIGHT; PLATE, FIXATION, BONE

Model Number 02.127.210

Device Problem Device-Device Incompatibility (2919)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2020

Event Type  malfunction  

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.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 on (b)(6) 2020, the patient underwent an open reduction internal fixation (orif) right lateral tibia plateau fracture.During the procedure, the cannulated interlocking bolt would not thread into the percutaneous aiming arm hole of a lateral proximal tibia plate.The procedure was successfully completed with a five (5) minute surgical delay.The patient outcome was good.Concomitant device reported: unknown nut (part#: unknown, lot#: unknown, quantity: 1); unknown insertion handle (part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) 3.5mm va-lcp prox tibia plate small bend/4h/87mm/right.This is report 1 of 3 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.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.

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.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: 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/4H/87MM/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: 10772383
• MDR Text Key: 214174338
• Report Number: 2939274-2020-04931
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982043467
• UDI-Public: (01)10886982043467
• Combination Product (y/n): N
• PMA/PMN Number: K120689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.127.210
• Device Catalogue Number: 02.127.210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS: TRAUMA.; UNK - NUTS.; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - NUTS
• Patient Age: 48 YR