MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JGRKNT 1.0MM MINI 2-0 NDLS; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number	912076
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.Visual examination of the returned product identified the device was returned in the product carton with the tyvek pouch already open.The device was in a plastic sleeve as well inside the tyvek pouch.The luer cap, sutures and needles remained in the handle of the device.The tip of the device is bent and the anchor is discolored/stained.Measured the position of the clear sleeve and it has moved from where it should be assembled per print.Part and lot information verified from packaging label.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event for a bent inserter is confirmed, however the cause for a bent inserter is unconfirmed.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.
Event or Problem Description
No further event information is available at the time of this report.
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 tip of the inserter was already bent when the nurse opened the package.There was no harm, injury, surgical/medical intervention to patient and no record of a delay.Due diligence is complete.No additional information is available.

• Brand Name: JGRKNT 1.0MM MINI 2-0 NDLS
• Common Device Name: SCREW, FIXATION, INTRAOSSEOUS
• 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: 21293297
• Report Number: 0001825034-2025-00246
• Device Sequence Number: 7746658
• Product Code: DZL
• UDI-Device Identifier: 00880304520820
• UDI-Public: (01)00880304520820(17)280922(10)0002553697
• 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): 04/16/2025

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 Catalogue Number: 912076
• Device Lot Number: 0002553697
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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