MAUDE Adverse Event Report: UMKIRCH CABLE CUTTER; CUTTER, WIRE

Catalog Number 03.607.513

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).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.Manufacturing location: (b)(4).Manufacturing date: september 30, 2014.No non-conformance reports 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 investigation could not be completed; no conclusion could be drawn, as no product was received.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 during an intramedullary (im) nailing of a femur using trochanteric fixation nail advanced (tfna) procedure on (b)(6) 2016, the cable cutter pliers broke; the device broke along the jaw of the device.The broken piece of the device was not retrieved and an alternate cable cutter device was used to complete the procedure successfully without any surgical delay.There was no reported patient harm.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

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 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

A product investigation was completed: the 03.607.513 lot number 9091519 cable cutter was returned and reported to have broken during surgery.This complaint condition was likely caused by the application of excessive force during cutting; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.This complaint is confirmed.Per the technique guide, the 03.607.513 cable cutter is an instrument routinely used in the cerclage passer system.One of the distal jaws has broken at the distal hinge of the device.It is likely that the application of excessive force while cutting a cable has led to this complaint condition.The device was manufactured in september 2014 and is over a year old.The balance of the returned device is in otherwise good working condition with minimal visible wear.The relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.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): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer (Section G): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5548057
• MDR Text Key: 41898266
• Report Number: 3003862213-2016-10010
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.607.513
• Device Lot Number: 9091519
• Other Device ID Number: (01)10886982080585(10)9091519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/21/2016; 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• 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
• Patient Outcome(s): Required Intervention