MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 3-0 NDLS; 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	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: japan.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
It was reported that during surgery that the shaft of device cracked.There was no harm or injury to patient.A delay of approximately 15 minutes was reported as an alternate device was needed to complete the procedure.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).Visual examination of the returned product identified the device was returned with the support sleeve of the device pushed all the way back against the handle.There were no sutures or anchors/implants returned.The handle of the device has fractured and all the pieces were returned.Fracture surface artifacts of hackle marks, river lines, and a probable bending hinge suggest the bending overload failure mode.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to use error.Per the surgical technique for the device, "the angle of insertion must be the same trajectory as the pilot hole.Failure to do this could prevent insertion and deployment of the anchor." a summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.The reported event is confirmed as product was returned.However, based on evaluation of the returned product, this complaint no longer meets the definition of a reportable malfunction.Therefore, this complaint will be assessed as not reportable.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
No additional information is available regarding the incident.

• Brand Name: JGRKNT 1.0MM MINI 3-0 NDLS
• 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: 20517450
• Report Number: 0001825034-2024-02500
• Device Sequence Number: 8768048
• Product Code: MBI
• UDI-Device Identifier: 00880304523418
• UDI-Public: (01)00880304523418(17)281101(10)0002563441
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140908
• 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
• Report Date (Section B): 04/17/2025

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: 912082
• Device Lot Number: 0002563441
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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