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 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.

Event Description

It was reported that a ratcheting handle disassembled outside of surgery.There were no surgical or patient impacts.

Manufacturer Narrative

The returned handle was examined.It was returned disassembled into three pieces.There were no signs of damage or breakage to any of the components.The cause is unable to be determined since it is not known how the device was being used at the time of disassembly, however it could have occurred as a result of multiple washings, sterilization cycles, and repeated usage.

• 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: 7366353
• MDR Text Key: 103328320
• Report Number: 3012447612-2018-00303
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• 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: 03/13/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1