MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIPTIGHT ANKLE SYN SYS-SS; FASTENER, FIXATION/SPORTS MEDICINE

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02696.Medical products: item#: 909857, ziptight ankle syn sys-ss; lot#: 029210.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as hospital discarded the implant.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an ankle procedure two implants were used and were unable to be implanted in the patient.The first implant, became unusable while tensioning and implant tore off the end of the switch.The second implant, became unusable when part of the implant fell through the patient¿s fibula during tensioning.Subsequently the physician had to drill a new hole.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02696-1.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot 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.

Event Description

No further event information available at the time of this report.

• Brand Name: ZIPTIGHT ANKLE SYN SYS-SS
• Type of Device: FASTENER, FIXATION/SPORTS MEDICINE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12514935
• MDR Text Key: 272869645
• Report Number: 0001825034-2021-02697
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K083070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 909857
• Device Lot Number: 029210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE