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

Catalog Number 03.607.513

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history records review has been requested.(b)(4).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 the front cutter broke during a hip surgery on (b)(6) 2018.During the procedure, the surgeon used a different wire cutter that was on the back of the table.The procedure was completed successfully with a surgical delay of one-two (1-2) minutes to get another wire cutter.There were no fragments generated from the broken device.Cutters were removed from the case easily and completely.There was no patient consequence.This report is for a 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.Device history records review was completed for part# 03.607.513, lot# 9499513.Manufacturing location: umkirch, release to warehouse date: jul 07, 2015.The material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product development investigation was completed.Visual inspection performed at customer quality (cq) confirmed the condition of device breakage, which agrees with the reported complaint condition.The distal machined feature of the right handle which surrounds the pivot screw has broken in half.Half is retained in the left handle, and half is retained in the right handle.Front cable cutter assembly drawing and right handle component drawing were reviewed during this investigation.The 03.607.513 front cable cutter is a reusable instrument routinely used for treatment of periprosthetic fractures in the cerclage passer system.No product design issues or discrepancies were observed.The thickness at location of breakage measured 3.96mm (ca592) which is within specification of 4.0mm +0.02 / -0.05mm per right handle component drawing.A definitive root cause for the device breakage could not be determined based on the provided information.It is most likely that excessive force or rough handling has contributed.This complaint is confirmed however no product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative 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
• 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: 7549922
• MDR Text Key: 109484795
• Report Number: 2939274-2018-52332
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982080585
• UDI-Public: (01)10886982080585
• 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
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.607.513
• Device Lot Number: 9499513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1