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

Catalog Number 124799

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.The quick-connect adaption collar was found to have disassembled form the remainder of the device.There were no other malfunctions found during the evaluation.The cause cannot be determined since it is not known how the device was being used when the disassembly occurred.A review of the manufacturing records did not identify any issues which would have contributed to this event.

Event Description

It was reported that a ratcheting handle was found during a routine inspection to no longer ratchet correctly.However, evaluation by zimmer biomet personnel found that the handle had disassembled.There were no surgical or patient impacts associated with 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: 7034121
• MDR Text Key: 92805344
• Report Number: 3012447612-2017-00659
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2017

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: Other
• Device Catalogue Number: 124799
• Device Lot Number: 068020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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