MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TRIGGER HANDLE F/CABLE CUTTER; MISC, SURGICAL, ORTHO, INSTRUMENT

Catalog Number 03.221.007

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter is a company representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 unknown date the cable cutter with trigger handle was broken after wash.There was no patient involvement.This complaint involves one (1) device.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.H10 additional narrative: d4: lot number; d10 (concomitant medical products).H3 (device evaluated by mfr), h6: a product investigation was conducted.Visual inspection: the trigger handle (part#: 03.221.007, lot#: t138842, mfg 18-oct-2016) was received at us cq.2 springs, 1 button and a dowel pin were returned separated from the rest of the device which was still intact.Functional test: the trigger will not function since the springs, button and dowel pin fell apart.The complaint was not replicated since the device fell apart.The complaint is still confirmed since the components fell apart.Dimensional inspection: dimensional analysis was completed, the outer diameter of the dowel pin, measured and is within specification based on relevant drawing.Conclusion: 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.No new malfunctions were observed during the course of this investigation.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.H3 (device evaluated by mfr), h4 (device manufacture date), h6: a device history record (dhr) review was conducted: part number: 03.221.007, lot number: t138842, manufacturing site: tuttlingen, release to warehouse date: 18-oct-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.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: MISC, SURGICAL, ORTHO, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9149507
• MDR Text Key: 194680718
• Report Number: 2939274-2019-61137
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982076700
• UDI-Public: (01)10886982076700
• 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: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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: T138842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Date Manufacturer Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1