MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. HEAD-HEIGHT ADJUSTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	07.02060.001
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vital mis head-height adjuster with a twisted tip was discovered at a warehouse upon return from the field.Patient/surgical/event information was not provided.
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.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.A visual inspection revealed the tip is twisted/deformed.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for vitality head-height adjuster for the failure of deformation.The failure could possibly be attributed to the repeated usage and/or high torque of the instrument leading to the deformation.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.
Event or Problem Description
It was reported that a vital mis head-height adjuster with a twisted tip was discovered at a warehouse upon return from the field.Patient/surgical/event information was not provided.

• Brand Name: HEAD-HEIGHT ADJUSTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 23536604
• Report Number: 3012447612-2025-00356
• Device Sequence Number: 10202584
• Product Code: LXH
• UDI-Device Identifier: 03662663125512
• UDI-Public: (01)03662663125512(10)133791
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 07.02060.001
• Device Lot Number: 133791
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/26/2025
• 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: 11/12/2025
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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