MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. 30 HEXALOBE SET SCREW PROVISIONAL DRIVER QC SHAFT - GOLD TIP; SCREWDRIVER

Catalog Number 5006408

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

E1: phone number: (b)(6) 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.

Event Description

It was reported, that a warehouse discovered a fractured array set screw driver.After it was returned from a hospital.The hospital did not provide patient or surgical information with the returned device.

Manufacturer Narrative

If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

It was reported that a warehouse discovered a fractured array set screw driver after it was returned from a hospital.The hospital did not provide patient or surgical information with the returned device.

• Brand Name: 30 HEXALOBE SET SCREW PROVISIONAL DRIVER QC SHAFT - GOLD TIP
• 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: 18469881
• MDR Text Key: 332902651
• Report Number: 3012447612-2024-00001
• Device Sequence Number: 1
• Product Code: HXX
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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: 5006408
• Device Lot Number: PR59A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• 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