MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TOGGLELOC WITH ZIPLOOP INLINE; TENDON/LIGAMENT BONE ANCHOR, NON-BIOABSORBABLE

Catalog Number	110005087
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: poland.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.
Event or Problem Description
It was reported that the implant was fractured during insertion into the femoral canal.The thread was torn from the loop.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the device shows signs of use with discoloration on the suture.The sutures were returned all separate with one all white suture through the suture button.The saddle portion of the blue and white suture is frayed and broken.Product information confirmed from label.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event is confirmed from product return.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: TENDON/LIGAMENT BONE ANCHOR, NON-BIOABSORBABLE
• 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: 20683155
• Report Number: 0001825034-2024-02688
• Device Sequence Number: 12936825
• Product Code: MBI
• UDI-Device Identifier: 00880304567634
• UDI-Public: (01)00880304567634(17)280616(10)0002529622
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 0002529622
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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 Sex: Unknown