MAUDE Adverse Event Report: SYNTHES TUTTLINGEN WIRE CUTTER 220MM; CUTTER, WIRE

Catalog Number 391.930

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

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

Event Date 01/20/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device is an instrument and is not implanted/explanted.(b)(6).Device history record (dhr) review was performed on part # 391.930, lot # t953257: manufacturing date: 24-nov-2010.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All (b)(4) parts of the lot were checked 100% for important features and for function at the final inspection on 23-nov-2010.No non conformance reports (ncrs) were generated during production.The device was received, the investigation could not be completed, and 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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient underwent an open reduction internal fixation (orif) procedure on (b)(6) 2017 for open fracture of distal phalange of middle finger.During the surgery while cutting a 1.6mm k-wire in phalange, there was a sudden give away and the tip of the wire cutter got broken.Fragments were generated, but they were easily removed.On further close inspection rusted surface was noted on the broken area of wire cutter.Per surgeon it was probably because of cracks in the tip area.There was no patient harm and no prolongation of surgery occurred.Procedure was completed successfully without other medical intervention required.Concomitant device reported: unknown 1.6mm k-wire (part # unknown, lot # unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product development investigation was performed for the subject device (wire cutter 220mm, part number 391.930, lot number t953257).The subject device was returned shows that one tip is broken off as complained.There are also signs of corrosion visible at the broken surface.We assume that the corrosion at the broken surface is result of cleaning and decontamination after breakage.Wet residues from cleaning detergents may cause corrosion at rough surface as we have at this area.The broken surface it selves is homogenous what indicated material conformity.Visual investigation shows that the cutting edges are rounded and therefore blunt as result of many years in use.We suppose that mechanical overloading during use may have caused the breakage.Exceeding applied mechanical force as result of damaged cutting edges would be most probability root cause.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: WIRE CUTTER 220MM
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6331939
• MDR Text Key: 67495173
• Report Number: 9680938-2017-10020
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819024779
• UDI-Public: (01)07611819024779(10)T953257
• 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: 01/23/2017

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: Health Professional
• Device Catalogue Number: 391.930
• Device Lot Number: T953257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2010
• 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
• Treatment: ONE (1) UNKNOWN 1.6MM K-WIRE