MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TRIGGER HANDLE F/CABLE CUTTER; CUTTER,WIRE

Catalog Number 03.221.007

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.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

It was reported that on (b)(6) 2020 the piece that holds the trigger in place on the cable cutter broke off when the cutter was being used to cut a 1.7mm stainless steel cable.There was no surgical delay reported.The procedure was successfully completed.There was no patient consequence.Concomitant device: unknown stainless steel cable (part# unknown, lot# unknown, quantity# 1).This report is for one (1) trigger handle f/cable cutter.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: visual inspection: the trigger handle f/cable cutter (p/n: 03.221.007, lot #: t157114) was returned and received at us cq.Upon visual inspection, it was observed that the device was missing the m4 shoulder nut and bolt.The device was not observed to be broken.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: there was conclusive evidence that the returned device was missing components, so the dimensional inspection was not performed.Document/specification review the following document(s) were reviewed: cable cutter handle with trigger: (current and manufactured).M4 shoulder nut: (current and manufactured).M4 shoulder bolt: (current and manufactured).No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the complaint was confirmed for the trigger handle f/cable cutter (p/n: 03.221.007, lot #: t157114) as the device was missing the m4 shoulder nut and bolt components.There is no indication that a design or manufacturing issue has caused the complaint condition 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: part number: 03.221.007.Lot number: t157114.Manufacturing site: (b)(4).Release to warehouse date: march 14, 2018.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.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: TRIGGER HANDLE F/CABLE CUTTER
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10390846
• MDR Text Key: 202587802
• Report Number: 2939274-2020-03452
• Device Sequence Number: 1
• Product Code: HXZ
• 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
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.221.007
• Device Lot Number: T157114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK : STAINLESS STEEL CABLE