MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. ROD GRIPPER; CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	07.02100.001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that the screw on a vitality rod gripper broke during a surgery.The parts were retrieved both inside and outside the surgical field.There was no patient harm and only a 20 minute delay.
Event or Problem Description
It was reported that the screw on a vitality rod gripper broke during a surgery.The parts were retrieved both inside and outside the surgical field.There was no patient harm and only a 20 minute delay.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.An inspection of the part shows the screw that connects the tips has fractured leading to the disassembly of the device.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for vitality rod gripper for the failure of fracture.The failure is believed to be attributed to damage over time and repeated usage of the instruments.This device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: ROD GRIPPER
• Common Device Name: CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 23610713
• Report Number: 3012447612-2025-00370
• Device Sequence Number: 18442517
• Product Code: GDJ
• UDI-Device Identifier: 00889024010338
• UDI-Public: (01)00889024010338(10)133769
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2026

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 Catalogue Number: 07.02100.001
• Device Lot Number: 133769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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
• Patient Ethnicity: Non Hispanic