MAUDE Adverse Event Report: SYNTHES TUTTLINGEN TRIGGER HANDLE F/CABLE CUTTER; CUTTER,WIRE

Catalog Number 03.221.007

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part #: 03.221.007, lot #: t109307: manufacturing date: 20-mar-2015.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications confirm that the material, components and final product met inspection records and certification.All 32 parts of the lot were checked 100% for critical features and for function at the final inspection on 19-mar-2015 and all were found to be conforming.No non conformance reports (ncrs) were generated during manufacturing.A product investigation was performed.The 03.221.007, lot number t109307, cable cutter handle with trigger assembly was returned with a missing shoulder bolt.The shoulder bolt mates with the shoulder nut to attach the trigger to the handle.This complaint is confirmed.The trigger is disassembled from the cable cutter handle due to the missing shoulder bolt.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already missing a shoulder bolt.The cable cutter is part of the orthopedic cable system.Once the wire is tensioned, the cutter is used to trim the wire close to the crimp without fraying the cable.The cable cutter assembly (03.221.006) is composed of the cable cutter handle with trigger assembly (03.221.007) and cable cutter blade assembly (03.221.008).Although a definitive root cause could not be determined, it is likely that this complaint condition was due to rough handling during surgery/sterile processing and cumulative wear, causing loose components and misplacement.Relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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 a cable cutter part was found broken in sterile processing.The device cannot function due to a missing screw.No patient or case was involved.Concomitant devices reported: blade for cable cutter (part #: 03.221.008, quantity: 1).This report is for one (1) trigger handle f/cable cutter.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TRIGGER HANDLE F/CABLE CUTTER
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6804329
• MDR Text Key: 83040346
• Report Number: 9680938-2017-10127
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982076700
• UDI-Public: (01)10886982076700(10)T109307
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• 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: T109307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BLADE (PART # 03.221.008, LOT # UNKNOWN, QTY 1)