MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. RATCHETING SCREW INSERTER T-HANDLE; WRENCH (RATCHETING HANDLES)

Catalog Number 124797

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2017

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 a t-handle was found disassembled after post-operative washing.The disassembly did not occur during surgery and did not have any patient involvement.

Manufacturer Narrative

Additional information: the returned handle was examined.The handle was returned in a disassembled configuration and there were no obvious indications of damage to any of the components.The cause of this failure can likely be attributed to loosening of the device components from use/ cleaning/ sterilization/ processing over time.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: RATCHETING SCREW INSERTER T-HANDLE
• Type of Device: WRENCH (RATCHETING HANDLES)
• 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: 7106918
• MDR Text Key: 94507245
• Report Number: 3012447612-2017-00676
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 124797
• Device Lot Number: 067971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2015
• 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