MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERKNOT DISPOSABLE SET; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	912041
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, a black foreign substance was found attached to the tip of the drill guide.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign, the event occurred in japan.The customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was discarded by the hospital.The investigation is in process.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.

• Brand Name: JUGGERKNOT DISPOSABLE SET
• 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: 25595582
• Report Number: 0001825034-2026-01874
• Device Sequence Number: 12133011
• Product Code: MBI
• UDI-Device Identifier: 00887868511851
• UDI-Public: (01)00887868511851(17)280326(10)0002503508
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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
• Device Catalogue Number: 912041
• Device Lot Number: 0002503508
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown