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 1 of 2 for (b)(4).

Manufacturer Narrative

Product complaint#: (b)(4).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, h6: the device was received, the investigation is in progress, 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.

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- the complaint condition was not confirmed for 3.5mm tplo plate.The lot that this part was manufactured has met all dimensional and visual criteria at the time of release for shipment with no issues documented that would contribute to the complaint condition.It has been concluded any damage, breakage, gouges/scratches or out of specification condition due to damage occurred after the product left manufacturing.Since no manufacturing related issue was identified and/or confirmed, a review to the specific prm and prm line is not applicable.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot = part number: vp4401.L3-us, lot number: 97p0585, part manufacture date: 27-march-2021, part expiration date: n/a, non conformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5mm tplo plate/left product was processed through the normal manufacturing and inspection operations with no rework, nor nonconformances 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.A review of the raw material device history record revealed this lot met all specifications with no nonconformances noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint.This lot met all dimensional, visual, and packaging criterial at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 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: 11910738
• MDR Text Key: 268314631
• Report Number: 2939274-2021-02696
• Device Sequence Number: 1
• Product Code: HRS
• 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
• Device Lot Number: 97P0585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 06/29/2021
• 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.