MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT SINGLE LOADED SOFT ANCHORS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	912031
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, the tip of the inserter fractured during use.The surgery was finished without removing the fractured piece of inserter from the patient's body, so the piece was retained.No additional patient harm was reported as a result of the event.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in japan.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 which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6.Visual evaluation was completed and found that the device was fractured.The device was submitted for further analysis.Fracture analysis has been previously analyzed in which a bending overload was identified as the mode of failure.Medical records were not provided.Device is used for treatment.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event was 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: JUGGERKNOT SINGLE LOADED SOFT ANCHORS
• 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: 23544665
• Report Number: 0001825034-2025-03602
• Device Sequence Number: 9458137
• Product Code: MBI
• UDI-Device Identifier: 00880304509627
• UDI-Public: (01)00880304509627(17)290116(10)0002582346
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/24/2026

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: Health Professional
• Device Catalogue Number: 912031
• Device Lot Number: 0002582346
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown