MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIPTIGHT ANKLE SYN FIX SYS-TI; PROSTHESIS, SPORTSMED

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	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) concomitant medical products item# 904759; ziptight ankle syn fixation-ti; lot# 253590.Item# 904759; ziptight ankle syn fixation-ti; lot# 253590.Item# 904759; ziptight ankle syn fixation-ti; lot# 080100.Report source foreign: event occurred in (b)(6).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04710, 0001825034-2019-04711, 0001825034-2019-04712.
Event or Problem Description
It was reported that during surgery while reducing the device, the suture fractured.There was a delay of 1.5 hours as a result of this event.Attempts have been made and additional information on the reported event is unavailable.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was confirmed by a review of the provided picture.Visual examination identified that the device is pictured with the needle, white suture separate from the toggle.The top hat button is free and the rest of the assembly is missing.Device history record was reviewed and no discrepancies were found.The root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: PROSTHESIS, SPORTSMED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9261702
• Report Number: 0001825034-2019-04709
• Device Sequence Number: 3671503
• Product Code: MBI
• UDI-Device Identifier: 00880304476097
• UDI-Public: (01)00880304476097
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K083070
• 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): 04/22/2020

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: 04/23/2023
• Device Model Number: N/A
• Device Catalogue Number: 909853
• Device Lot Number: 691940
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 04/22/2020
• 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
• Patient Age: 50 YR