MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.5MM #2 MB SNGL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery that the device fractured and was retained by the patient.There was no reported harm, injury, or medical/surgical intervention.There is no plan for any surgical intervention to remove the foreign particle.A delay of approximately 15 minutes was reported while the surgeon considered course of action with regards to the retained device.The surgery was finished using the same device.Due diligence is complete.No additional information is available.
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
No additional information is available regarding the incident.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, d4, g1, g3, g6, h2, h6, h11.The following sections have been corrected: d4.Visual examination of the provided pictures identified a prong has fractured off the inserter, and further down the inserter is bent.Fracture analysis has been previously analyzed where bending overload was identified as the mode of failure.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed from provided pictures.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 further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the inserter shaft is bent at the distal end of the juggerknot and the tip of the inserter shaft is fractured and not all of the pieces have been returned.Fracture analysis has been previously analyzed where a bending overload was identified as the mode of failure.The juggerknot was returned without any packaging materials/components.The foam sleeve, sutures and anchor were not returned.The luer cap is stall attached to the handle.Product information cannot be confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.It remains that a definitive root cause cannot be determined.It remains that the reported event is confirmed from provided pictures and product return.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: JGRKNT 1.5MM #2 MB SNGL
• 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: 20545323
• Report Number: 0001825034-2024-02529
• Device Sequence Number: 18111172
• Product Code: MBI
• UDI-Device Identifier: 00880304509627
• UDI-Public: (01)00880304509627(17)290119(10)0002583822
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 912031
• Device Lot Number: 0002583822
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 06/09/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 01/21/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown