MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT SOFT ANCHORS JUGGERKNOT SHORT; 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	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in poland.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 a guide tooth broke, which prevented placement of the implant.Attempts have been made and no further information has been provided.

• Brand Name: JUGGERKNOT SOFT ANCHORS JUGGERKNOT SHORT
• 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: 25082756
• Report Number: 0001825034-2026-01202
• Device Sequence Number: 16093306
• Product Code: MBI
• UDI-Device Identifier: 00880304509641
• UDI-Public: (01)00880304509641(17)290813(10)0002658934
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K110145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: 0002658934
• 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: 04/09/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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