MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. OPEN SET SCREW FINAL DRIVER; SCREWDRIVER

Catalog Number	ASY-00375
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported that three linesider drivers had twisted/fractured tips, and one had a twisted tip.No patient, surgical, or event information was provided.This is report two of four for this event.
Additional Manufacturer Narrative
D4: the remainder of the udi number is unknown because the lot number is not available.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore, the device history records are unable to be reviewed.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.Reference reports 3012447612-2025-00327 through 3012447612-2025-00330.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.The device was not returned for evaluation.The lot number was not provided, so the dhr was unable to be reviewed.The complaint is confirmed by photo for (1) of (1) returned linesider open set screw final driver (pn asy-00375) for the failure of tip deformation and fracture.The failure could possibly be attributed to the repeated usage and/or high torque of the instrument leading to the deformation and fracture of the device.This device is used for treatment.
Event or Problem Description
A distributor reported that three linesider drivers had twisted/fractured tips, and one had a twisted tip.No patient, surgical, or event information was provided.This is report two of four for this event.

• Brand Name: OPEN SET SCREW FINAL DRIVER
• 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: 23380355
• Report Number: 3012447612-2025-00328
• Device Sequence Number: 8815626
• Product Code: HXX
• UDI-Device Identifier: 00810004727779
• UDI-Public: (01)00810004727779
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: ASY-00375
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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