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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery to repair meniscus that the juggerstitch implant broke the inserter.There was no reported harm or injury to patient and no reported delay.Due diligence complete for this complaint.No additional information is available.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: poland.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
No additional information is available regarding the incident.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).Visual examination of the provided photo identified the depth stop assembly has been removed from the inserter/handle.Due to the quality of the photo, the needle fracture cannot be seen.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.The reported event is unable to be confirmed.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
Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, e1, e2, e3, g3, g6, h2, h3, h6, h11.Visual examination of the provided photo identified the depth stop assembly has been removed from the inserter/handle.Visual examination of the returned product identified the device has been cycled 2 times.The sutures and both anchors were out of the needle upon receipt in our lab.The adjustable depth gage was on the needle however not attached to the front-end assembly and was just sitting loose on the needle.There is nothing broken or fractured on the device as the adjustable depth gage is to be able to come off the front-end assembly and the needle.No problem was found with the returned device.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.

• 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: 20236078
• Report Number: 0001825034-2024-02206
• Device Sequence Number: 8754915
• Product Code: MBI
• UDI-Device Identifier: 00880304690066
• UDI-Public: (01)00880304690066(17)281214(10)66457705
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K191459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2026

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 Model Number: N/A
• Device Catalogue Number: 110024772
• Device Lot Number: 66457705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 02/05/2025; 01/15/2026
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 02/13/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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