MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ZIPTIGHT AC JOINT 1 ZIPLOOP; FASTENER, FIXATION

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that patient underwent an ac joint reconstruction procedure utilizing a fixation device on an unknown date.Subsequently, the fixation device loosened and the joint has separated.There has been no revision procedure reported to date.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 3 states, "loosening or migration of the implant.".

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that patient underwent an ac joint reconstruction procedure utilizing a fixation device on (b)(6) 2014.Subsequently, the fixation device loosened and the joint has separated.There has been no revision procedure reported to date.

• Brand Name: ZIPTIGHT AC JOINT 1 ZIPLOOP
• Type of Device: FASTENER, FIXATION
• 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: 3848882
• MDR Text Key: 4615884
• Report Number: 0001825034-2014-05202
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/03/2014

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 Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 904834
• Device Lot Number: 993390
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 06/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2013
• 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): Required Intervention