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

Catalog Number 03.221.006

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.No patient involvement reported.Implant and explant dates: device is an instrument and is not implanted/explanted.Date returned to manufacturer.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part #: 03.221.006; lot #: 2034.Dhr was not available as device is older than 15 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to (filing and archiving of specification documents) version ai, which was in place till (b)(6)2014.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.The cable cutter was determined to be broken after it was reported that a missing screw is causing the device not to function properly.No patient or surgeon was involved.This complaint is for one (1) device.Concomitant devices report: [blade for cable cutter] (part #: 03.221.008, lot #: unknown, quantity: 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Corrected data: the initial complaint was reviewed and found not reportable as the component part number 03.221.006 was inadvertently reported.Part number should have been 03.221.007 (trigger handle f/cable cutter) and will be reported on the other report.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): 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: 6723591
• MDR Text Key: 80511047
• Report Number: 9680938-2017-10123
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10886982076694
• UDI-Public: (01)10886982076694(10)2034
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.221.006
• Device Lot Number: 2034
• 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: 08/17/2017
• Was Device Evaluated by Manufacturer?: No
• 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