MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. SCREW DRIVER; VITALITY SPINAL FIXATION SYSTEM, VITALITY®+ POWER INSTRUMENT SYSTEM

Catalog Number 731M0000

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported two screwdrivers have warped tips and are difficult to disengage from screw.No information related to patient impacts was provided.This is report two of two for this event.

Event Description

It was reported two screwdrivers have warped tips and are difficult to disengage from screw.No information related to patient impacts was provided.This is report two of two for this event.

Manufacturer Narrative

Inspection the device was not returned and no photos were provided, so an evaluation is unable to be performed.Dhr review the lot number was not provided, so the dhr was unable to be reviewed.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.This event could also be attributed to off-axis forces applied during use.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.Reference report 3012447612-2023-00247.

• Brand Name: SCREW DRIVER
• Type of Device: VITALITY SPINAL FIXATION SYSTEM, VITALITY®+ POWER INSTRUMENT SYSTEM
• 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17652449
• MDR Text Key: 322309745
• Report Number: 3012447612-2023-00248
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172275
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 731M0000
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic