MAUDE Adverse Event Report: Zimmer Biomet, Inc. JUGGERSTITCH CURVED IMPLANT; 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	07/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that resistance was encountered when operating the lever, and the anchor could not be withdrawn from the device.It was confirmed that the suture was tangled inside.No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This device is sold outside the us and therefore no gudid information exists.This device is considered similar to (b)(4).G2: japan.G6: pre-market submission number of similar product: k191459.The customer has indicated that the product will not be returned to zimmer biomet for investigation since it was discarded.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: JUGGERSTITCH CURVED IMPLANT
• 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: 50077324
• Report Number: 0001825034-2026-02213
• Device Sequence Number: 16032263
• Product Code: MBI
• UDI-Device Identifier: 00887868575068
• UDI-Public: (01)00887868575068(17)300604(10)0989871
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/29/2026

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: 0989871
• 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: 07/03/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2025
• 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