MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERSTITCH STRAIGHT IMPLANT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	110024772
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in poland.Complaint can be confirmed through the returned product analysis.Fracture analysis has been previously analyzed for this fracture location where overload was identified as the mode of failure.Visual examination of the returned product identified the device has not been cycled and both anchors remain inside the needle tip with a portion of the suture still attached.The pusher wire with teeth is bent at the distal end of the juggerstitch and the needle tip has fractured.Confirmed that there is no flashing present and the handle is translucent green in color.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found 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 the tip of the needle fractured intra-operatively during implant placement.It was reported that no further information is available.

• Brand Name: JUGGERSTITCH STRAIGHT 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 ; 5745260384
• MDR Report Key: 24191568
• Report Number: 0001825034-2026-00228
• Device Sequence Number: 18520107
• Product Code: MBI
• UDI-Device Identifier: 00880304690066
• UDI-Public: (01)00880304690066(17)270926(10)417730
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K150424
• 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): 01/27/2026

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: 110024772
• Device Lot Number: 417730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• 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: 12/30/2025
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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