MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SHEAR OFF FINAL DRIVER; SCREWDRIVER

Catalog Number 730M0002

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2020

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 that the shear off final driver was sticking in the mating shear off closure tops during surgery.It was successfully used to complete the surgery without impacts to the patient.

Manufacturer Narrative

Information added to d8, h6: component codes, type of investigation, investigation findings, investigation conclusions this follow-up report is being submitted to relay additional information.Summary the complaint is unrefuted for one (1) of one (1) vital driver (pn 730m0002) for the failure of binding to set screws.Medical records were not provided for review.Device evaluation: product was not returned and photos were not provided, so the failure could not be confirmed.Additionally, lot number was not provided, so dhr review and lot based analysis could not be performed.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review and related actions lot number is not known, so dhr review could not be performed.No actions required.This event is not related to any current actions or recalls or product holds.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

Was reported that the shear off final driver was sticking in the mating shear off closure tops during surgery.It was successfully used to complete the surgery without impacts to the patient.

• Brand Name: SHEAR OFF FINAL DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10942987
• MDR Text Key: 219509625
• Report Number: 3012447612-2020-00668
• 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: 04/14/2021

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: 730M0002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1