MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TOGGLELOC WITH ZIPLOOP INLINE; FASTENER, FIXATION

Model Number	110005087
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source foreign: (b)(6).Customer has indicated that 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.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 or Problem Description
It was reported that a knee arthroscopy was performed and during cinching, the suture fractured from the button.No adverse event has been reported as a result of the malfunction.
Event or Problem Description
No additional event information is available at the time of this report.
Additional Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified a small loop of blue/white sutures connected to the button, with frayed areas on the loop.There were long strings of sutures also returned with frayed ends.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: TOGGLELOC WITH ZIPLOOP INLINE
• Common Device Name: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11526910
• Report Number: 0001825034-2021-00790
• Device Sequence Number: 11748521
• Product Code: JDR
• UDI-Device Identifier: 00880304567634
• UDI-Public: (01)00880304567634(17)250929(10)457390
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K130033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: 09/29/2025
• Device Model Number: 110005087
• Device Catalogue Number: 110005087
• Device Lot Number: 457390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR