MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. QC TORQUE WRENCH HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 94522

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/27/2018

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.Reference report 3012447612-2018-00429.

Event Description

It was reported that a torque limiting handle did not limit the torque output during use and caused the pentalobe drive feature of the mating plug to strip during installation.An alternative torque handle and plug were used to complete the procedure without reported patient impacts.This is report two of two for this event.

Manufacturer Narrative

The returned torque wrench was evaluated.The torque output was confirmed to be outside of the range.There were no signs of abnormal wear found.Handles found out of calibration typically exhibit spring relaxation, wear of critical torque components, and/or break down of the internal lubrication from use over time.A review of the manufacturing records did not identify any issues which may have contributed to this event.

• Brand Name: QC TORQUE WRENCH HANDLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7530854
• MDR Text Key: 108866934
• Report Number: 3012447612-2018-00430
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

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: 94522
• Device Lot Number: 818794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 10/01/2018
• Supplement Dates FDA Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1