MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TOGGLELOC WITH ZIPLOOP INLINE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE

Catalog Number	110005087
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the surgeon pulled the button the thread fractured, causing the surgeon to not be able to use the product.Attempts have been made to obtain additional information.No additional information has been received at this time.
Additional Manufacturer Narrative
(b)(4).G2: foreign: india.H3: 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h5, h6, h11 visual examination of the returned product identified that one blue/white suture was returned, and one white suture was returned with the button loop on the suture.The saddle of the blue/white sutures were not returned.There is a knot in the blue/white suture with another one started.Just below the fully tied knot shows the ends are frayed.Item and lot numbers are confirmed with the returned patient label.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A review of the complaint history identified additional similar complaints for the reported item, but no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.The reported event is confirmed from the product return.A definitive root cause cannot be determined.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
There is no update to the prior event description provided.

• Brand Name: TOGGLELOC WITH ZIPLOOP INLINE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21740033
• Report Number: 0001825034-2025-00937
• Device Sequence Number: 4046231
• Product Code: MBI
• UDI-Device Identifier: 00880304567634
• UDI-Public: (01)00880304567634(17)271130(10)0002485455
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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 Catalogue Number: 110005087
• Device Lot Number: 0002485455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Male