MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIPTIGHT ANKLE SYN FIX SYS-TI; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
Event or Problem Description
It was reported the device fractured during use.No further information is available at the time of this reporting.
Event or Problem Description
No additional event information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified only the blue/white suture and the two buttons were returned.It can be confirmed the blue/white suture is broke.Visual inspection of the short button found that there are nicks and burrs, predominantly on its top surface where the suture does not travel along.Visual inspection of the top hat button identified it was free of nicks and burrs.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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 ANKLE SYN FIX SYS-TI
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9529771
• Report Number: 0001825034-2019-05734
• Device Sequence Number: 16997895
• Product Code: MBI
• UDI-Device Identifier: 00880304476097
• UDI-Public: 00880304476097
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2024
• Device Model Number: N/A
• Device Catalogue Number: 909853
• Device Lot Number: 450760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1