MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #301

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problem 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 two of two for the same event, see also 0001032347-2015-00427.

Event Description

The facility reported two elevators broke during a procedure.The broken pieces were retrieved and no adverse events were reported.

Manufacturer Narrative

Upon visual inspection, the complaint has been confirmed that the tip is broken.The ifu for this part 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 device history was reviewed and no non-conformance was found for this lot.There are no indication of manufacturing defects.The most likely underlying cause is excessive force.Supplemental report two of two for the same event, see also 0001032347-2015-00427-1.

• 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: 5189151
• MDR Text Key: 30283744
• Report Number: 0001032347-2015-00428
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2015

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: 111111K11
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2015
• Initial Date FDA Received: 10/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2011
• 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