MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. PLUG DRIVER; SCREWDRIVER

Catalog Number 2000-9061

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  malfunction  

Event Description

It was reported that two polaris plug drivers have twisted tips that can no longer perform final tightening.This was discovered during inspection at a hospital.There was no patient impact.This is report one of two for this event.

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, that two polaris plug drivers have twisted tips.That can no longer perform final tightening.This was discovered, during inspection at a hospital.There was no patient impact.This is report one of two for this event.

Manufacturer Narrative

Corrections in d4: lot number.Additional information in d4: udi number.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.Reference report (b)(4).

• Brand Name: PLUG DRIVER
• Type of Device: 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 19091224
• MDR Text Key: 340604661
• Report Number: 3012447612-2024-00066
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00880304893566
• UDI-Public: (01)00880304893566(10)ZB6783692
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 2000-9061
• Device Lot Number: ZB6783692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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