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 Material Twisted/Bent (2981)

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.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

It was reported that on an unknown date during a tibial plateau leveling osteotomy, the thread on one of the locking self-tapping holes (caudal head of plate) was not threaded right or cross threaded.The lst screw drill guide was not able to screw into one of those holes.3 tplo plates were opened, and all were the same.There was an unknown surgical delay.The procedure was successfully completed.There were no patient consequences.Concomitant device reported: unknown: drill guides: (part# unknown; lot# unknown; quality:1).Unknown: screw: (part# unknown; lot# unknown; quality: unknown).This complaint involves (5) devices.This report is for (1) 3.5mm tplo plate/right 3 holes.This report is 1 of 5 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.A1, a2, a3, a4: device used in a veterinary case - no patient information will be reported.H3, h6: part number: vp4401.R3-us lot number: 98p7454 part manufacturing date: 05 april 2021 manufacturing site: elmira 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 98p7454 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# 98p7454) was returned and received at the jabil elmira 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 jabil elmira manufacturing facility.Device failure/defect identified? no dimensional inspection: thru hole (feature d2) result: pass thread pitch diameter (feature h7) result: pass thread minor diameter (feature d7) result: pass ball mill depth (feature h1) result: 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# 98p7454).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.

• 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
• MDR Report Key: 12229577
• MDR Text Key: 264134625
• Report Number: 2939274-2021-04285
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982012197
• UDI-Public: (01)10886982012197
• 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
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• 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: 98P7454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Date Manufacturer Received: 08/17/2021
• Patient Sequence Number: 1
• Treatment: 3.5MM TPLO PLATE/RIGHT 3 HOLES.; 3.5MM TPLO PLATE/RIGHT 3 HOLES.; UNKNOWN - DRILL GUIDES.; UNKNOWN - SCREW.