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

Model Number 391.905

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Device history records review was conducted.The report indicates that the: part number: 391.905, synthes lot number: t993448, release to warehouse date: 24-july-2013, manufacture site: (b)(6), part expiration date: n/a, list of nonconformance¿s: n/a.A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.No ncrs were generated during the production of this device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(6) documented the following: it was reported that two (2) cable cutters broke during a primary sternotomy procedure on (b)(6) 2018.The surgeon was attempting to cut a zipfix with the cable cutters and the products did not function as intended.Two reinforce metal blades were added to the cutters and one of the two blades fell off and separated from the instruments on two occasions.Fragments were retrieved, nothing was left in the patient.Another cable cutter was used to complete the procedure.No surgical delay or patient harm were reported.Patient outcome was reported stable.The devices were previously used.No unusual use of the devices were reported.Concomitant devices reported: zipfix (unknown part and lot numbers, quantity unknown).This complaint involves two devices.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device: this complaint is confirmed.One of the carbide inserts/distal cutting jaws has sheared off and is missing.The remainder of the cutting jaws area shows post manufacturing wear/damage consistent with significant use.The returned cable cutter was manufactured in july 2013 and is over 4 years old.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Whether this complaint can be replicated at customer quality (cq) via functional test is not applicable for this complaint condition as the returned device is already broken.Drawing was reviewed during this investigation.No product design issues or discrepancies were observed.The returned cable cutter-standard is a reusable instrument available in the sternal zipfix system and spine cable system.In the spine cable system, the cable cutter is intended to be used to cut the leader portions off of the double lead cable implants.In the sternal zipfix system, the cable cutter is intended to be used to cut the needle portion off of the sternal zipfix implants.No product design issues or discrepancies were observed during this investigation.A dimensional inspection of features relevant to this complaint could not be obtained at cq due to the post manufacturing damage.Unfortunately, we are not able to determine the exact cause which has led to this occurrence.As all the parts of this lot were tested, at the final inspection, we conclude that the cause is not due to any manufacturing non-conformances.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.

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.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.

• Brand Name: CABLE CUTTER-STANDARD
• 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: 7341618
• MDR Text Key: 103150791
• Report Number: 2939274-2018-51066
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982198396
• UDI-Public: (01)10886982198396(10)T993448
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2018

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 Model Number: 391.905
• Device Catalogue Number: 391.905
• Device Lot Number: T993448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 04/10/2018; 05/08/2018
• Supplement Dates FDA Received: 05/02/2018; 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1