MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNIVERSAL INSERTER/EXTRACTOR; INSTRUMENT, MANUAL

Model Number N/A

Device Problems Break (1069); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under precautions, "surgical instruments are subject to wear with normal usage." examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition; the device showed signs of wear, impact marks on the handle, and the handle was cracked.A conclusive root cause of the event could not be determined.

Event Description

It was reported the inserter handle has become worn over time.The issue was not found during a procedure.

• Brand Name: UNIVERSAL INSERTER/EXTRACTOR
• Type of Device: INSTRUMENT, MANUAL
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5682164
• MDR Text Key: 46007609
• Report Number: 0001825034-2016-01757
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 31-473601
• Device Lot Number: ZB120901
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1