MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE ZIPTIGHT FIXATION SYSTEM SYNDESMOSIS FIXATION DEVICE; FASTENER

Catalog Number 904759

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).

Event Description

During the procedure, while the surgeon was attempting to pass the device sutures and button through the fibula/tibia tunnel, the button became stuck in the fibula and did not reach its desired location for fixation.The sutures were cut and the device was removed from the patient.Another device was utilized to complete the procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIPTIGHT FIXATION SYSTEM SYNDESMOSIS FIXATION DEVICE
• Type of Device: FASTENER
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6266225
• MDR Text Key: 65372656
• Report Number: 0001825034-2016-05497
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK083070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/03/2020
• Device Catalogue Number: 904759
• Device Lot Number: 825620
• Other Device ID Number: REFERENCE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2016
• Initial Date FDA Received: 01/20/2017
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2015
• 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