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

Model Number 03.221.006

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021 the cable cutter was used.It was discovered in the sterile processing the device fell apart.A piece broke or came apart from the handle of the cable cutter.There was no patient involvement.This report is for a cable cutter.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

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.H3, h4, h6: part number: 03.221.006.Lot number: t124559.Manufacturing site: (b)(4).Release to warehouse date: (b)(6)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.Visual inspection: the cable cutter handle with trigger (p/n: (b)(6) & lot #: t124559) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the m4 shoulder bolt (03_221_007_08) came out causing pusher (03_221_007_02) and trigger(03_221_007_03) to fell apart from 03.221.007 assembly.The potential cause of the complaint condition cannot be confirmed.No other issues were identified with the device.Functional test: the functional test cannot be performed as the matting device (cable cutter blade assembly 03_221_008) was not returned.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: a dimensional inspection was not performed as it's not pertaining to complaint condition.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed (current & manufactured).Complaint confirmed? yes, since the subcomponents fell apart causing the alleged complaint condition.Investigation conclusion: the complaint condition can be confirmed for the device.However the root cause of the complaint condition cannot be confirmed.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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: CABLE CUTTER W/TRIGGER HANDLE
• 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: 12408760
• MDR Text Key: 281014509
• Report Number: 2939274-2021-05095
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982076694
• UDI-Public: (01)10886982076694
• 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: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.221.006
• Device Catalogue Number: 03.221.006
• Device Lot Number: T124559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1