MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TL REMOVAL HEXALOBE BIT 15; SCREWDRIVER

Catalog Number 14-501731

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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 the tip of a hexalobe screw removal bit broke off during surgery while removing a competitor's previously-implanted screw.The pieces were removed and discarded.Another driver was used to complete the procedure.There were no patient impacts associated with this event.

Event Description

It was reported that the tip of a hexalobe screw removal bit broke off during surgery while removing a competitor's previously-implanted screw.The pieces were removed and discarded.Another driver was used to complete the procedure.There were no patient impacts associated with this event.

Manufacturer Narrative

Additional information in h6: methods, results, and conclusions.The complaint is unrefuted for one unreturned tl removal hexalobe bit 15 for the failure of instrument fractured.Since the product was not returned, an exact cause can not be determined.The dhr can't be located despite attempts at due diligence.No actions required.This event is not related to any current actions or recalls or product holds.This device is used for treatment.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.

• Brand Name: TL REMOVAL HEXALOBE BIT 15
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11156319
• MDR Text Key: 226327841
• Report Number: 3012447612-2021-00009
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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: 14-501731
• Device Lot Number: 220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1