MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SPINAL ROD CUTTER MAXIMUM PIN DIAMETER 6.4 MM (1/4 IN.); CUTTER, WIRE

Catalog Number	00392500200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2 user facility report number (b)(4).The device will not be returned for analysis; however, and investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that during surgery that the wire cutter fractured.All pieces were removed from the patient's wound and no pieces were retained.There was no reported harm, injury, surgical/medical intervention to patient and no report of a delay.Due diligence is complete.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following section was corrected: h10.
Event or Problem Description
No additional information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h4, h6, h11.Visual examination of the provided photo identified one of two jaws is fractured, with the tip of the jaw broken off.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported instrument fracture is attributed to a design deficiency.The root cause of using the reported device after the device was recalled is attributed to user error.6 recall notifications were sent to the associated hospital where the hospital was instructed to immediately locate and quarantine affected product in your inventory.The reported event has been confirmed by provided photo.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.

• Brand Name: SPINAL ROD CUTTER MAXIMUM PIN DIAMETER 6.4 MM (1/4 IN.)
• Common Device Name: CUTTER, WIRE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21677690
• Report Number: 0001822565-2025-00709
• Device Sequence Number: 8349387
• Product Code: HXZ
• UDI-Device Identifier: 00889024067165
• UDI-Public: (01)00889024067165(11)160415(10)63328164
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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: 00392500200
• Device Lot Number: 63328164
• Was Device Available for Evaluation?: No
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 05/16/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/01/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown