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

Catalog Number 03.607.513

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the item broke as described as the surgeon attempted to cut our 1.7mm cable.The fragment that snapped off flew out of the operating site and landed on the floor.It was retrieved and disposed of by the circulating staff.The patient was not harmed and the surgery continued without delay as the set has a different cutter which was used to cut the cable.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history review was conducted.The report indicates that the following anomalies were detected during device history record review: for the first nine pages of the sap work instructions/records, the pagination is not complete (e.G."page 4 of asterisk"), and in various points, e.G.Page 8 and 9, more components were used than forecasted by the instructions.These issues are not relevant to the current complaint, because they regards good documentation practice and component tally, while the complaint is about the braking of a complete device.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this 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.

Manufacturer Narrative

Additional narrative: product received for manufacturer review/investigation on (b)(4) 2015.Subject device has been received and is currently in the evaluation process.Cable cutter.Device is 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

Device was used for treatment, not diagnosis.Additional narrative: a product development evaluation was performed for the subject device.The subject device was received with the counter part of the wire guiding block broken out.The manufacturing documents of the front cutter in question were reviewed and no complaint related issues were found.The correct material was used with 1.4112 and as well the hardness was 54.5 hrc within the specification of 52 +4/0 hrc.The fracture face is homogenous, which indicates material conformity.This lot of (b)(4) pieces was manufactured in february 2014, all devices of this lot are sold and we are not aware of any other complaint for this article- and lot number.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.The investigation has shown that the corner above the stopper on the side of the cutter is broken off.This corner is normally not exposed to any force during the cutting procedure and there is a clear gap between the stopper and the corner in the closed position of the front cutter.Even the cutting edges hardly hit together after cutting the surface where the corner is broken off does not touch the stopper.Therefore, it can only be assumed that something was between the stopper and the broken corner during the cutting procedure which led to a mechanical overload as this corner is not designed to take any force.While the compliant condition is confirmed, no product design or manufacturing fault could be detected.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-79 224; GM D-79224
• Manufacturer (Section G): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-79 224; GM D-79224
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4361418
• MDR Text Key: 5232750
• Report Number: 3003862213-2014-10046
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2014

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: Health Professional
• Device Catalogue Number: 03.607.513
• Device Lot Number: 8827090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 12/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2015; 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2014
• 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