MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT 1.4MM SHRT W/NDLS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	912068
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the thread broke while the doctor was tying the knot, and no clamping instrument was used.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).G2: foreign, event occurred in taiwan.The 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, d9, g3, g6, h2, h3, h6, h11.Visual examination of the returned product identified signs of use as well as wear and tear.The foam insert with tab and needles are no longer in the handle.The single loaded implant subassembly is no longer attached to the handle.None of these items were returned with the device.The luer cap is present and installed on the device as shown in the photos.Measured features of the handle to confirm the device is conforming to print specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: JUGGERKNOT 1.4MM SHRT W/NDLS
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 23973482
• Report Number: 0001825034-2026-00056
• Device Sequence Number: 9064170
• Product Code: MBI
• UDI-Device Identifier: 00880304509641
• UDI-Public: (01)00880304509641(17)290809(10)0002658930
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110145
• 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): 05/29/2026

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: 912068
• Device Lot Number: 0002658930
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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