MAUDE Adverse Event Report: BIOMET MICROFIXATION SMITH WIRE CUTTER STRAIGHT 16 CM TC

Model Number N/A

Device Problems Fracture (1260); Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that after the doctor cut the wire on an arch bar, he noticed a tiny piece of the tip was broken off.It is reported it would not cut properly on the first and second use.It is reported, however not confirmed, that suction was used to remove the tip from the patient.It is reported that there was no delay and the doctor does not consider this event to be a patient injury.Additional information was requested but not received.

Manufacturer Narrative

The product was returned for evaluation.The product identity was confirmed in the evaluation.A visual inspection revealed moderate signs of wear including minor scratches along the length of the instrument and a fracture at the very tip of the cutting blade; therefore the complaint is confirmed.The most likely underlying cause was determined to be excessive force applied at the tip.The non-conformance database was reviewed in the evaluation and no non-conformances were found.According to the evaluation, there are no indications of manufacturing defects.

• Brand Name: SMITH WIRE CUTTER STRAIGHT 16 CM TC
• Type of Device: WIRE CUTTER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6103729
• MDR Text Key: 59935006
• Report Number: 0001032347-2016-00676
• 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: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-0928
• Device Lot Number: 022213B13
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention