MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXFORD SPHER CUTTER LRG; INSTRUMENT, MANUAL

Model Number N/A

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2016

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 the 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 storage and shelf life, it states, "instrument cases that have been processed and wrapped to maintain sterility should be stored in a manner to avoid extremes in temperature and moisture." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-02238/ 02239).

Event Description

After initial sterilization, it was noticed that the instrument exhibited signs of corrosion.There was no patient involvement.

• Brand Name: OXFORD SPHER CUTTER LRG
• 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: 5745370
• MDR Text Key: 48053128
• Report Number: 0001825034-2016-02239
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• 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: 32-420331
• Device Lot Number: ZB150903
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1