MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIPTIGHT ANKLE SYNDESMOSIS FIXATION SYSTEM; FESTENER, FIXATION

Model Number N/A

Device Problem Device Expiration Issue (1216)

Patient Problem No Information (3190)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Potential for infection due to compromised sterility.Reported event was able to be confirmed by comparing the surgery date to the expiration date.No issues were identified with the labeling or electronic data for the expiration date.The packaging for this product has been tested and validated.As long as the sterile barrier is not damaged or opened, the medical device will remain sterile through its shelf life of 5 years from sterilization.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause determined to be the labeling was not adequately checked prior to implantation (user error).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.

Event Description

It was reported that the patient underwent an orif fibula syndesmosis.Following the procedure, it was noticed by the surgeon that the implant that was implanted had passed its sterile expiration date.No adverse effect reported at this time.

• Brand Name: ZIPTIGHT ANKLE SYNDESMOSIS FIXATION SYSTEM
• Type of Device: FESTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7318250
• MDR Text Key: 101664185
• Report Number: 0001825034-2018-01188
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK083070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/06/2017
• Device Model Number: N/A
• Device Catalogue Number: 909853
• Device Lot Number: 061030
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR