MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OXFORD KEEL BLD STK HUB; CUTTER, WIRE

Model Number N/A

Device Problem Device Expiration Issue (1216)

Patient Problem No Information (3190)

Event Date 03/25/2014

Event Type  Injury  

Event Description

It was reported patient underwent left partial knee arthroplasty on (b)(6) 2014.During the procedure, a sterile blade that was expired was used.The surgery was completed without issue.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of receiving certificate of conformance showed that lot released with no recorded anomaly or deviation.

• Brand Name: OXFORD KEEL BLD STK HUB
• Type of Device: CUTTER, WIRE
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3772994
• MDR Text Key: 4357119
• Report Number: 0001825034-2014-03284
• Device Sequence Number: 1
• Product Code: HXZ
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 506109
• Device Lot Number: 985223
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention