MAUDE Adverse Event Report: SYNTHES (USA) CABLE CUTTER-LARGE; CUTTER,WIRE

Catalog Number 391.906

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/02/2014

Event Type  malfunction  

Event Description

It was reported that during veterinary surgery for a fracture repair on a radius bone on a canine while cutting the wire the surgeon noticed that both cutting instruments were chipped.The surgeon used another instrument that was available to complete the surgery.This resulted in an additional 5 minutes added to surgery time.It was reported that no fragments were observed during surgery.The surgery was completed successfully.No human patient was involved.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device used in a veterinary case.No patient information will be reported.Device is an instrument and is not implanted/explanted.The lot number provided could not be verified the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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-LARGE
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3898513
• MDR Text Key: 21526579
• Report Number: 2520274-2014-12208
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2014

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: 391.906
• Device Lot Number: D274140000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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