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

Catalog Number 909867

Device Problem Disconnection (1171)

Patient Problem Failure of Implant (1924)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

Physician placed the device with no noted problems.Patient claims that one week after the surgery the wire was disconnected and the toe returned to its pre-operative posture.

• Brand Name: ZIPTIGHT
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): BIOMET, INC.; 56 east bell drive; po box 587; warsaw IN 46581
• MDR Report Key: 3933948
• MDR Text Key: 17578455
• Report Number: 3933948
• Device Sequence Number: 1
• Product Code: MBI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 909867
• Device Lot Number: 385840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2014
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 84