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 Type  malfunction  

Event Description

It was reported that the cable cutter is missing a screw.This report is 1 of 1 for (b)(4).

Event Description

The extraction screw is having a threading problem.

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn as no product was received.A review of the device history records has been requested.Device 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

Additional narrative: subject device has been received and is currently in the evaluation process.A device history review was conducted.The report indicates that there were no issues during the manufacture of the product that would contribute to this complaint condition.The raw material which was delivered as lot #712004 is corresponding to the specifications.The hardness was measured at the time of the manufacturing between 45-47,5 hrc and was found to be good.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

Additional narrative: a product investigation was completed: the cable cutter with trigger is one of three devices able to be used to cut cables in the orthopaedic cable system.The three potential cutters which can be used to cut cables include the standard cable cutter (391.905), the large cable cutter (391.906), and the cable cutter with trigger handle.The blade for cable cutter (03.221.008) was also returned but the complaint was specific to part (03.221.007).The returned cable cutter with trigger handle was manufactured on november 16, 2011.The relevant drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.The returned device was received disassembled with the m4 shoulder bolt missing.The m4 shoulder bolt and nut mate with each other in the trigger handle to serve as a hinge and ensure that the trigger remains attached to the body of the trigger handle.Based on the available information it is not possible to determine an accurate root cause for the complaint condition.Upon inspection of the m4 shoulder nut which was returned, neither the exterior of the nut nor the inner threading which interacts with the m4 shoulder bolt indicated any damage which would contribute to the complaint condition.It is possible that the missing m4 shoulder bolt was lost during sterile processing after the device was disassembled and not properly re-assembled post sterilization with all the essential components.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: TRIGGER HANDLE F/CABLE CUTTER
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4459088
• MDR Text Key: 5181045
• Report Number: 9680938-2015-10016
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• 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: T932014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2011
• 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