MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL; PLIERS,SURGICAL

Model Number 03.130.270

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is a sales representative.For photo investigations: the instrument(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed and the complaint condition for broken could be confirmed as the image provided shows the broken device.As the instrument(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.A device history record (dhr) review was conducted: part number: 03.130.270, lot number: t126575, manufacturing site: (b)(4), release to warehouse date: 10.01.2016.Dhr and raw material certificates were review.No ncs were identified.All material certificates are according to the specification.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a wrist and hand procedure on (b)(6) 2020, when the surgeon was cutting the plate with the plate cutter, the cutter gave way and broke when trying to cite a 2.0mm plate.No fragments generated.Another cutter was used.Procedure was successfully completed without any surgical delay.No patient consequences reported.Concomitant device reported: unknown plate hand (part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) plate cutter/in-line for 1.3mm lckng/1.5-2.0mm val pl.This is report 1 of 1 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.H3, h4, h6: part 03.130.270, lot t126575: manufacturing site: tuttlingen.Release to warehouse date: january 10, 2016.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.H3, h6: a product investigation was completed: visual inspection of the complaint device showed one of the cutting jaws had broken off.A dimensional inspection was not performed due to post-manufacturing damage.The relevant documents were reviewed.No design issues or discrepancies were identified.This complaint is confirmed as one of the cutting jaws had broken off.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that 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: PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL
• Type of Device: PLIERS,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10574726
• MDR Text Key: 208178531
• Report Number: 2939274-2020-04287
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10886982075468
• UDI-Public: (01)10886982075468
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.130.270
• Device Catalogue Number: 03.130.270
• Device Lot Number: T126575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: HAND; UNK - PLATES: HAND.