MAUDE Adverse Event Report: SYNTHES USA SMALL WIRE CUTTER 230MM; CUTTER, WIRE

Catalog Number 391.94

Device Problem Crack (1135)

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

Event Date 05/10/2011

Event Type  malfunction  

Event Description

It was reported that during a pinning procedure on a hand (right or left on reported), the surgeon was using the small wire cutter to cut a wire and the cutting edge cracked.Nothing fell into the patient and the surgeon was able to complete the procedure with no adverse effect to patient.This report is 1 of 1 for devices complaint (b)(4).

Manufacturer Narrative

Synthes is submitting this report as a result of remediation activities.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Device is an instrument and not implanted/explanted.A review of the device history records was performed and no complaint related issues were found.Product development evaluation: instrument corresponds to drawings and processes at the time of manufacture.Too much force was applied to the instrument causing them to break.Hardness is ok.Deemed invalid.

• Brand Name: SMALL WIRE CUTTER 230MM
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380
• MDR Report Key: 4368576
• MDR Text Key: 5260928
• Report Number: 2520274-2014-05131
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2011

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: 391.94
• Device Lot Number: T946386
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2011
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2011
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2010
• 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