MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. MAS INSERTER 465 CW; SCREWDRIVER

Catalog Number LV01144

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

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 3012447612-2020-00702.

Event Description

It was reported a mas inserter broke while removing a previously-implanted screw and a universal screw inserter while installing a replacement screw during a revision surgery.The tip of the first inserter remained in the removed screw.The tip of the second inserter remains captured in the replacement screw head under the rod.A third driver was used to successfully complete the procedure.This is report one of two for this event.

Manufacturer Narrative

Corrected information in d4: udi number and h3.Additional information in d8, h4, and h6: component, investigation type, findings, and conclusions.This follow-up report is being submitted to relay additional information.The complaint is confirmed for two returned inserters for the failure of tip fracture during operation.Visual inspection of the returned devices reveals that both tips are fractured.Medical records were not provided for review.Potential cause: the cause of the damage cannot be determined at this time since there is no information available regarding how the inserters were being used or handled at the time of the damage.Dhr review and related actions: the dhr was reviewed.There driver was likely conforming when it left zimmer biomet's control.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported a mas inserter broke while removing a previously-implanted screw and a universal screw inserter while installing a replacement screw during a revision surgery.The tip of the first inserter remained in the removed screw.The tip of the second inserter remains captured in the replacement screw head under the rod.A third driver was used to successfully complete the procedure.This is report one of two for this event.

• Brand Name: MAS INSERTER 465 CW
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11119022
• MDR Text Key: 226106542
• Report Number: 3012447612-2020-00701
• 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: 03/19/2021

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: LV01144
• Device Lot Number: 309905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1