MAUDE Adverse Event Report: BIOMET INC. BMP CABLE SYSTEM; CERCLAGE, FIXATION

Model Number 350805

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/17/2015

Event Type  malfunction  

Event Description

Crimp failed to hold cable in place.

• Brand Name: BMP CABLE SYSTEM
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): BIOMET INC.; 56 east bell dr.; po box 587; warsaw, IN 46581
• MDR Report Key: 5309868
• MDR Text Key: 33847914
• Report Number: 5309868
• Device Sequence Number: 1
• Product Code: JDQ
• 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: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 350805
• Device Lot Number: 564270
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1