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 08/20/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age was not available for reporting.Device is an instrument and is not implanted/explanted.(b)(6).A device history record review was performed for the complaint device lot.The device lot was manufactured by synthes (b)(4).Manufacturing date: mar 17, 2016.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 complaint device.The subject device has been received by the manufacturer and is currently undergoing evaluation.The results of the evaluation are pending completion.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 an initial nailing procedure, the cable cutter broke into two pieces during use.After the surgeon inserted the nail and was attempting to affix a bone fragment with a cable, the cable cutter broke while cutting the cable after it was tensioned.The instrument broken into two pieces but these pieces were easily retrieved.The procedure was completed with another cable cutter.The surgery was completed successfully without delay.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A manufacturing evaluation was completed: the device was received broken.The manufacturing document shows that all manufacturing and assembling steps were performed correctly.All inspection steps were performed and show no deviations to specifications.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacturing of the product.The hardness measurements of the broken part (in the mouth of instrument) and of the mouth of instrument have been performed and show no deviations in hardness from the specification.During manufacturing investigation all relevant and significant dimensional characteristics from the device were measured.All checked characteristics are within the specifications.There are no references to the reported issue that a product failure caused the breakage.It is likely that mishandling was led to the breakage.No manufacturing related issue was identified and/or confirmed.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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5930886
• MDR Text Key: 54024163
• Report Number: 3003862213-2016-10028
• 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: 08/20/2016

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: 9846512
• Other Device ID Number: (01)07611819880313(10)9846512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2016
• Initial Date FDA Received: 09/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2016
• 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 Weight: 70