MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT SOFT ANCHORS SINGLE LOADED 1 MAXBRAID - BLUE/WHITE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	912030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in japan.The customer has indicated that the product is in the 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 is found that 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
It was reported that during the surgery, the tip of the inserter fractured during use.The surgery was completed successfully and the fractured piece of the inserter was removed from the patient.The case was completed without any adverse outcomes to the patient.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; e1; e2; e3; g1; g3; g6; h1; h2; h3; h6.The reported event is confirmed through returned product analysis.Visual examination of the returned product identified that the distal end of the device has fractured and all pieces were returned.Confirmed that the handle of the device is visually conforming to the print.Device was submitted for further analysis.Fracture analysis identified the fracture showed excessive smearing and biological debris near the edges and corners.Ductile dimple artifacts identified in the clean, non-smeared regions of the fracture surface, suggesting an overload mode of failure.Eds semi-quantitative elemental analysis of product needle sample showed that the composition is consistent with nitinol.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found that 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 is available at the time of this report.

• Brand Name: JUGGERKNOT SOFT ANCHORS SINGLE LOADED 1 MAXBRAID - BLUE/WHITE
• 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: 22390953
• Report Number: 0001825034-2025-01958
• Device Sequence Number: 13051466
• Product Code: MBI
• UDI-Device Identifier: 00880304477193
• UDI-Public: (01)00880304477193(17)290820(10)0002662692
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150768
• 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): 12/16/2025

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: 912030
• Device Lot Number: 0002662692
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 12/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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