MAUDE Adverse Event Report: SYNTHES TUTTLINGEN WIRECUTTER LRG W/CANTILEVER L220; CUTTER,WIRE

Catalog Number 391.930

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/04/2014

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information provided.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.The raw material which was delivered as lot #205027 is corresponding to the specifications.The hardness was measured at the time of the manufacturing at 47 hrc and was found to be good.No ncrs were generated during production.Subject device has been received and is currently in the evaluation process.

Manufacturer Narrative

A manufacturing evaluation was completed: the visual inspection of this returned wire cutter shows that the cutting blade is indeed badly damaged; the cutting surface is partly broken off on several spots.It is likely that simply too much mechanical force has been applied during the procedure or the cutter was not used according to instruction.This wire cutter should not be used for wires larger then ø 2 mm.The manufacturing documents do show conformity to the specifications.The instrument met fully to our specifications at the time when it was distributed.No product or material related condition was found.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 while using cutting instrument it was not able to cut the wires and was cutting the edges and breaking them into pieces.It was also reported that there was no patient involvement.This is report 1 of 1 for complaint (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 review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: WIRECUTTER LRG W/CANTILEVER L220
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3698731
• MDR Text Key: 11842112
• Report Number: 9680938-2014-10007
• 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: 03/05/2014

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: 391.930
• Device Lot Number: T996102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 03/25/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/14/2014; 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2013
• 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