MAUDE Adverse Event Report: Zimmer Biomet, Inc. JuggerStitch®; Fastener, fixation, nondegradable, soft tissue

Catalog Number	110024773N
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an anchor didn't deploy during surgery.The correct surgical technique was used.No complications, injuries, or surgical interventions were reported, and the procedure was completed with an alternate device.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).E1: full establishment name - (b)(6).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.If any further information is found that would change or alter any conclusions or information, a supplemental medwatch 3500a will be submitted.

• Brand Name: JuggerStitch®
• 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 ; +1(574)526-0384
• MDR Report Key: 50712850
• Report Number: 0001825034-2026-02727
• Device Sequence Number: 10585917
• Product Code: MBI
• UDI-Device Identifier: 00887868575068
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191459
• 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): 09/10/2026

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: 110024773N
• Device Lot Number: 0919191
• 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: 08/14/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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