MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BENDING/CUTTING PLIERS; PLIERS,SURGICAL

Model Number 391.962

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 (b)(6) 2020, the bending/cutting pliers broke while trying to cut an unknown plate.Fragments were generated and were removed easily without additional intervention.There was no surgical delay.Procedure was successfully completed.Patient outcome is unknown.Concomitant device reported: unk-plate (part# unknown; lot# unknown; quantity: 1).This is report 1 of 1 of (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.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

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.H10 additional narrative: d10: device received.H3, h4, h6: a review of the device history record.Part number: 391.962.Lot number: t958883.Manufacturing site: tuttlingen.Release to warehouse date: 31-may-2011.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: summary background: 1/14/2020: updated event description: it was reported that on (b)(6) 2020, the bending/cutting pliers broke while trying to cut an unknown plate.Fragments were generated and were removed easily without additional intervention.There was no surgical delay.Procedure was successfully completed.Patient outcome is unknown.Concomitant device reported: unk-plate (part# unknown; lot# unknown; quantity: 1).This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the bending/cutting pliers (p/n:391.962, lot #: t958883) was returned and received at us cq.Upon visual inspection, the carbide insert was missing on the cutting slot of the device and the device was observed to be functioning loose.There were scratches and slight discoloration observed on the device but has no impact on the functionality of the device.No other issues were observed with the returned components of the device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.Bending/cutting plier: 391_962, rev.J/f.The device received was missing carbide insert.Hence confirming the allegation.Investigation conclusion.The complaint condition is confirmed for the bending/cutting pliers (p/n:391.962, lot #: t958883).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 history lot no devices with part number 391.962 and lot number t958383 were manufactured.Based on the at the complaint level attached picture the correct lot number could be t958883, therefore the dhr review was performed for this lot: 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: BENDING/CUTTING PLIERS
• 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: 9655542
• MDR Text Key: 191553511
• Report Number: 2939274-2020-00595
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10886982198525
• UDI-Public: (01)10886982198525
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 391.962
• Device Catalogue Number: 391.962
• Device Lot Number: T958883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - PLATES.