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

Catalog Number 03.607.513

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot number 9964511.Manufacturing location: synthes (b)(4).Date of manufacture: aug 21, 2015.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 reported an event in (b)(6) as follows: it was reported that during a trochanteric femoral nail insertion procedure to treat a sub-trochanteric femoral fracture on (b)(6) 2016, the tip of the cable cutter broke.The surgeon attempted to cut a 1.7mm cerclage cable which had been implanted around the bone to hold the fracture reduction prior to insertion of the titanium trochanteric fixation nail advanced (tfna).While attempting to trim the excess cerclage cable the tip of the cable cutter snapped off when cutting the cable.The surgeon managed to successfully cut the cable with the instrument and retrieve the small broken tip.The surgeon commented that he may have caught the cable cutter on the cerclage crimp of the cable assembly in situ.The reported event did not result in a negative impact to the patient's outcome or surgical delay.The surgery was continued as planned.Concomitant device: one, 611.105.01s, 1.7mm cocr cable with ti crimp 750mm-sterile, lot number unknown.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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.

Event Description

October 31, 2016: updated information, could not confirm exactly how this complaint occurred, no further information was available because the received material for investigation was not returned to our location and complaint will be closed.

• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6060336
• MDR Text Key: 58528272
• Report Number: 3003862213-2016-10032
• Device Sequence Number: 1
• Product Code: HXZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

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: 9579224
• Other Device ID Number: (01)07611819880313(10)9579224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2015
• 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
• Treatment: 611.105.01S, 1.7MM COCR CABLE