MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM/2.7MM T-PLATE/7 HOLES 85MM-VETERINARY; PLATE, FIXATION, BONE

Catalog Number VP1342.07

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

510k#: device is a veterinary product.No patient information will be reported.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

This report is for a veterinary case.There was no human patient involvement.It was reported that the canine patient returned for a follow-up on (b)(6) 2018 following an unknown procedure that occurred on (b)(6) 2018.During the follow-up, the patient showed no sign of pain and presented using her leg well.The surgeon noted the curvature in the bone of the leg and ordered radiographs.It was discovered that the plate (3.5mm/2.7mm t-plate/7 holes 85mm) had bent inside of the patient.A revision surgery took place on (b)(6) 2018 to remove the plate and screws.New plates and screws from a different vendor were put in the patient.The revision surgery was successfully completed with no harm to the patient.The surgeon and vet tech believed the plate to be weak or malleable.Vet tech went to test durability on another synthes plate (3.5mm/2.7mm t-plate/9 holes 105mm) and could easily bend it with her own hands.Concomitant devices reported: screw (part number unknown, lot number unknown, quantity unknown) this report is for one (1) 3.5mm/2.7mm t-plate-veterinary this is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# vp1342.07, lot# h312675.Manufacturing location: (b)(4), manufacturing date: mar 22, 2017.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 3.5/2.7 t-plate/7 holes 85mm veterinary plates was processed through the normal manufacturing and inspection operations with no non-conformance 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.The review of the raw material device history record revealed this lot met all specifications with no non-conformance 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 condition.Product investigation was completed.The device was received bent.The complaint condition was visually confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the devices were returned damaged.Relevant drawings were reviewed.Dimensional analysis was completed, the thickness of the plate proximal to the bend, measured 2.05 mm (caliper (b)(4)).This is within specification of 1.90 to 2.20 mm, based on the drawing.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces prior to bone healing.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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/2.7MM T-PLATE/7 HOLES 85MM-VETERINARY
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7422058
• MDR Text Key: 105421560
• Report Number: 2939274-2018-51589
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982008961
• UDI-Public: (01)10886982008961(01)H312675
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VP1342.07
• Device Lot Number: H312675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1