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

Catalog Number VP4401.R3

Device Problem Device-Device Incompatibility (2919)

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

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Veterinary complaint: it was reported that on an unknown date, upon visual inspection the caudal screw hole in the head of the tibial plateau leveling osteotomy (tplo) plate threads did not look correct.There was no patient involvement.There is no further information available.This report is for one (1) 3.5mm tplo plate/right 3 holes.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Part number: vp4401.R3.Lot number: 99p0398.Part manufacturing date: 05 april 2021.Manufacturing site: (b)(4).Part expiration date: n/a.Nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot 99p0398 of 3.5 mm tplo plates was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This 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 condition.A review of the raw material device history record(s) determined the raw material lot 71p2267 met all specifications with no issues documented that would contribute to this complaint condition.Visual inspection: the 3.5mm tplo plate/right 3 holes (part# vp4401.R3, lot# 99p0398) was returned and received at the (b)(4) manufacturing facility.A visual inspection of the device shows the plate appears to be in the same acceptable conforming condition cosmetically as it was when it shipped from the (b)(4) manufacturing facility.Device failure/defect identified? no.Dimensional inspection: thru hole pass.Thread pitch diameter: pass.Thread minor diameter : pass.Ball mill depth: pass.Document/specification review: no design issues or discrepancies were found during this investigation.Complaint confirmed? no.Investigation conclusion: the complaint cannot be confirmed for 3.5mm tplo plate/right 3 holes (part# vp4401.R3, lot# 99p0398).A definitive root cause could not be identified for the reported problem.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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

There was a burr on the underside of the plate.

• Brand Name: 3.5MM TPLO PLATE/RIGHT 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
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12267643
• MDR Text Key: 264797434
• Report Number: 2939274-2021-04462
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VP4401.R3
• Device Lot Number: 99P0398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1