MAUDE Adverse Event Report: BIOMET, INC. TOGGLELOC; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 906535

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2017

Event Type  malfunction  

Event Description

When i was doing the charges for this surgery acl (anterior cruciate ligament) case, i discovered that the implant labeled acl in-a-box 11mm, one 11mm tunneloc ,one toggleloc with ziploop was expired.The expiration date was (b)(6) 2017.Reference # (b)(4), lot # 914170.Biomet sports medicine.

• Brand Name: TOGGLELOC
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): BIOMET, INC.; 56 east bell dr.; p.o. box 587; warsaw IN 46581
• MDR Report Key: 6452773
• MDR Text Key: 71506959
• Report Number: 6452773
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2017,03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2017
• Device Model Number: 906535
• Device Lot Number: 914170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; OTHER, PATIENT WAS HAVING SURGERY FOR HIS KNEE
• Patient Age: 56 YR