MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TOGGLELOC WITH ZIPLOOP; STAPLE, FIXATION, BONE

Catalog Number	110017308
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item# 110010371; lot# 0002689011.Item# 110027357; lot# 0002691747.Item# 110003539; lot# 0002662577.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown for the suture and remains implanted for the button.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which 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
It was reported that the patient underwent a revision surgery approximately two (2) months post-implantation due to the suture breaking where it connects to the button.Subsequently, it was noted that the old button was left in the patient and was not attempted to be removed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.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 event was unable to be confirmed.If any further information which 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
No further event information available at the time of this report.

• Brand Name: TOGGLELOC WITH ZIPLOOP
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 22608050
• Report Number: 0001825034-2025-02230
• Device Sequence Number: 5457946
• Product Code: JDR
• UDI-Device Identifier: 00880304812895
• UDI-Public: (01)00880304812895(17)281027(10)0002558977
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 110017308
• Device Lot Number: 0002558977
• Was Device Available for Evaluation?: No
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Sex: Male