MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. DORSAL HEIGHT ADJUSTER; SCREWDRIVER

Catalog Number	2000-9072
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection of a field return from a hospital, a warehouse discovered a defective polaris dorsal height adjuster.The hospital did not provide any patient or event information.Upon manufacturer investigation, it was found that the driver tip was fractured.
Additional Manufacturer Narrative
A review of the dhr was conducted and found no indications of manufacturing issues.An inspection of the part shows the tip is twisted and fractured.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for polaris 5.5 dorsal height adjuster for the failure of fracture.The failure could possibly be attributed to the repeated usage and/or excessive forces being applied beyond the intended use of the instrument leading to the fracture of the device.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: DORSAL HEIGHT ADJUSTER
• Common Device Name: SCREWDRIVER
• 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: 25196485
• Report Number: 3012447612-2026-00132
• Device Sequence Number: 13405327
• Product Code: HXX
• UDI-Device Identifier: 03662663191883
• UDI-Public: (01)03662663191883(10)P1902F
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2026

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: 2000-9072
• Device Lot Number: P1902F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• 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