MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #301

Model Number N/A

Device Problems Break (1069); Fracture (1260); Off-Label Use (1494)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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.Report four of four for the same event, see also 0001032347-2015-00420 (-1), 0001032347-2015-00474 and 0001032347-2015-00475.

Event Description

The facility reported they would like to return seven 301 elevators that are broken.No dates, surgery details, or patient information was able to be provided.The facility confirmed there were no adverse events.

Manufacturer Narrative

Upon visual inspection, the complaint has been confirmed that the tip is broken.The device history record was reviewed and no non-conformance was found for this lot.There are no indication of manufacturing defects.The ifu for this part (instructions for use) states that "the tip of the instrument is extremely thin and delicate, care should be taken to avoid applying significant pressure to the tip." the most likely underlying cause is excessive force.(b)(4).Supplemental report four of four from the same customer, reference 0001032347-2015-00420-2, 0001032347-2015-00474-1 and 0001032347-2015-00475-1.

• 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: 5256962
• MDR Text Key: 32578001
• Report Number: 0001032347-2015-00476
• 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,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: N/A
• Device Catalogue Number: 09-0257
• Device Lot Number: 111214K14
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• 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