MAUDE Adverse Event Report: SYNTHES TUTTLINGEN WIRECUTTER SM L160; CUTTER,WIRE

Catalog Number 391.900

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement was reported.Date of event is unknown.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Device is not distributed in the united states, but is similar to device marketed in the usa.Device history records review was completed for part# 391.900, lot# t127239.Manufacturing location: (b)(4), manufacturing date: feb 15, 2016.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.A review of inspection records and certifications, confirm that the components and final product met inspection records.All parts of the lot were checked for critical features and for function at the final inspection on jul 15, 2016.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 follow: it was reported that cutting area of a wire cutter was defective as the small pieces of device broke off.It is unknown when the issue occurred or when it was detected.No patient involvement reported.This report is for one (1) wire cutter.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: a small part at the tip of one leg is broken off.There are some scratches at the cutting edges detected.No other damages are visible.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 critical features and for function at the final inspection on 15-jul-2016.No ncrs were generated during production.Unfortunately without more information we are not able to determine the exact cause which has led to this occurrence.This kind of damage can occurred while using the instrument just on the front part of the cutting edges.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: WIRECUTTER SM L160
• 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: 6180524
• MDR Text Key: 62542645
• Report Number: 9680938-2016-10183
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819024762
• UDI-Public: (01)07611819024762(10)T127239
• 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,Followup
• Report Date: 11/24/2016

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: Physician
• Device Catalogue Number: 391.900
• Device Lot Number: T127239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/10/2017; 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• 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