MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #301

Model Number N/A

Device Problems Bent (1059); Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated, a follow up report will be sent upon completion of the product evaluation.Report four of four for the same complaint; see also 0001032347-2016-00053-1, 00125, 00126 and 00127.

Event Description

The facility reported four (4) 301 elevators broke at the tip during four different procedures.The dates and specific case details were unable to be provided, however it was confirmed that all parts of the instruments were retrieved and no adverse events were reported.

Manufacturer Narrative

All parts reported for this event were returned and evaluated for the complaint that the tips have broken.Based on the product evaluation, the complaint for this part and lot was unconfirmed with a bent tip instead of a broken tip.Based on the product evaluation, the most-likely underlying cause of the bent tip was determined to be the excessive force experienced during use outside of the intended use.There are no indications of manufacturing defects.This is report 4 of 4 for the same event.Reports 2, 3, and 4 are reported on mfr #0001032347-2016-00053-2, 0001032347-2016-00125-1, and 0001032347-2016-00126-1.

• Brand Name: ELEVATOR #301
• Type of Device: ELEVATOR
• 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: 5488535
• MDR Text Key: 39938210
• Report Number: 0001032347-2016-00127
• Device Sequence Number: 1
• Product Code: EMJ
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

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 Model Number: N/A
• Device Catalogue Number: 09-0257
• Device Lot Number: 012309L08
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 03/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2009
• 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