MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TPLO PLATE/LEFT 3 HOLES; PLATE, FIXATION, BONE

Catalog Number VP4401.L3

Device Problems Nonstandard Device (1420); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.

Event Description

It was reported that on an unknown date the patient underwent for a surgery.During an unknown procedure, the number of threads in the caudal screw hole in the head of the tibial plateau leveling osteotomy (tplo) plate seems too less.There was a little trouble with the drill guide sinking correctly in that caudal screw.There was an unknown surgical delay.Patient outcome is unknown.This complaint involves one (1) device.This report is for (1) 3.5mm tplo plate/left 3 holes.This report is 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h11 (corrected data): b1, b5, h1: the initial complaint was reviewed and found not reportable.The allegation is only regarding one plate.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.B1, b5, h1.

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: h4, h6: without a lot number the device history records review could not be completed.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 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.D7a: unknown.B1, b5, h1: the previous retraction follow-up-1 report was reported inadvertently.The initial complaint was reviewed again and based on the initially provided complaint information this report is still reportable to fda.

• Brand Name: 3.5MM TPLO PLATE/LEFT 3 HOLES
• 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: 11910737
• MDR Text Key: 268315118
• Report Number: 2939274-2021-02697
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982012180
• UDI-Public: (01)10886982012180
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VP4401.L3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3.5MM TPLO PLATE/LEFT 3 HOLES; UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - SCREWS: TRAUMA