MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH MENISCAL REPAIR DEVICE CURVED; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	110024773
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) e1: full establishment name - (b)(6).G2: foreign - event occurred in russia.Customer has indicated that the product will not be returned to zimmer biomet for investigation due to international shipping restrictions regarding medical devices from that particular country.The investigation is in process.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.
Event or Problem Description
It was reported that outside of a procedure, the juggerstitch was tested on a silicone meniscus.When attempting to insert the first implant, very heavy pressure on the implant's trigger had to be used and pushing out the first implant was difficult.The user heard a creaking sound as the first shot was attempted and eventually the first anchor came out, but was noted to be very thick, frayed, and short.Installing the second anchor required less effort; it looked better and was noted to be longer than the first, thinner, and smoother.When tightening the anchor, it was noted to be reluctant to take shape, requiring some effort and felt as though it's not tightening properly and was trying to come out without deforming.Attempts have been made and no further information has been provided.

• Brand Name: JUGGERSTITCH MENISCAL REPAIR DEVICE CURVED
• 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: 25185163
• Report Number: 0001825034-2026-01315
• Device Sequence Number: 10702183
• Product Code: MBI
• UDI-Device Identifier: 00880304690073
• UDI-Public: (01)00880304690073(17)291120(10)67038563
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 05/15/2026

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: 110024773
• Device Lot Number: 67038563
• 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: 04/27/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Patient Sex: Unknown