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

Catalog Number 03.607.513

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted / explanted.Reporter contact number (b)(6).Device history records review was completed for part# 03.607.513, lot# 3435562.Manufacturing location: (b)(4), manufacturing date: jul 16, 2010.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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

Device report from synthes europe reports an event in as follows: it was reported that on (b)(4) 2017, during surgery the staff wanted to cut a cerclage wire with diameter of 1.55mm.While doing this the front part of the cable cutter broke into two pieces.The surgery was not prolonged and the patient outcome was reported as good.The surgery was completed successfully.Concomitant reported part: coil with cerclage wire 1.5mm, length, 10 mm, stainless steel (part#/lot# unknown, quantity 1).This report is for one (1) cable cutter.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Patient height reported as 1 meter 71 centimeters.A product investigation was completed: the investigation has shown that the one prong of the front cutter is broken off; the broken off part was also returned for investigation.The review of the production histories revealed that this front cutter was manufactured in july 2010 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.The hardness was measured and complies with the specification.The broken surface is homogenous what indicates material conformity as well.Further investigation has shown the cutting edge is blunt and shows clear signs of use, which is to be expected for multiuse instruments.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformance's and it is likely that a mechanical overload during use caused this breakage.The stopper on the side of the cutter is usually not exposed to any force during the cutting procedure as there is a clear gap between the stopper and the corner in closed position.It is likely that an obstacle of any kind was between the stopper and the corner during the cutting procedure and did additionally lead to a mechanical overload as this corner is not designed to take any force.The complaint is determined not to be a result of a detected manufacturer deficiency, damage appears to be the result of repeated use and wear over the life of the devices.No product related issues identified.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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6634679
• MDR Text Key: 77512175
• Report Number: 3003862213-2017-10016
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819880313
• UDI-Public: (01)07611819880313(10)3435562
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

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: Physician
• Device Catalogue Number: 03.607.513
• Device Lot Number: 3435562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 07/03/2017
• Supplement Dates FDA Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2010
• 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 Age: 58 YR
• Patient Weight: 82