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	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the screws/pegs at the tip of a vitality rod gripper fractured intra-op, and that the piece broke while under stress after being secured to a rod in the thoracic spine.The piece was retrieved, and a secondary device was available to use for the rest of the procedure.There was no patient or procedural impact.
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow-up report will be sent upon completion of the device evaluation.

• 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: 24689350
• Report Number: 3012447612-2026-00082
• Device Sequence Number: 13256152
• Product Code: GDJ
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: 110870
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• 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: 03/25/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• 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 Age: 67 YR
• Patient Sex: Female