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 Problems Foreign Body In Patient (2687); No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.Because the lot number is unknown, the device history records could not be pulled and reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report two of two for the same event.Report one of two is reported on mfr #0001032347-2016-00592.

Event Description

It was reported that the scissors "have a chip on tip" and are not cutting properly on the first and second uses.

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.This is report two of two for the same event.Report one of two is reported on mfr #0001032347-2016-00592-1.

Event Description

Additionally, it was confirmed that a tiny piece of the tip broke off during a procedure while the doctor was cutting the wire on an arch bar.It is reported the doctor noticed the broken tip after the wire was cut.It is reported that suction was used to try to remove the tip from the patient.However, it was not confirmed if the removal attempt was successful.It is reported that this event did not cause a delay and the doctor does not consider this a patient injury.

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 product, a piece of black tape wrapped around the handle, and a fracture at the very tip of the cutting blade; therefore the complaint is confirmed.The most-likely 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.This is report two of two for the same event.Report one of two is reported on mfr #0001032347-2016-00592-2.

• 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: 6034297
• MDR Text Key: 57642088
• Report Number: 0001032347-2016-00593
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• 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,Followup
• Report Date: 09/19/2016

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: 09/19/2016
• Initial Date FDA Received: 10/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/21/2016; 11/23/2016
• 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): Other; Required Intervention