MAUDE Adverse Event Report: ZIMMER SPINE TORQUE LIMITING T-HANDLE; INSTINCT JAVA SYSTEM

Catalog Number 046W1AN00650

Device Problem Calibration Problem (2890)

Patient Problem No Code Available (3191)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

The returned torque limiting handle was evaluated.The torque output was found to be above the specification limit.The calibration due date was (b)(6) 2015.However, the device was not returned for calibration and this event occurred approximately 18 months after the calibration expired.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding the proper usage of the device.This handle was used with the driver reported on 3003853072-2016-00145.

Event Description

It was reported that a driver broke during final tightening within surgery.There was not an allegation associated with the torque limiting handle, but device evaluation found that the handle was outputting torque above specification.There was a surgical delay greater than 30 minutes, but there were no reported patient impacts associated with the delay.

• Brand Name: TORQUE LIMITING T-HANDLE
• Type of Device: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• Manufacturer (Section G): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7658139
• MDR Text Key: 113007023
• Report Number: 3003853072-2018-00055
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: PK111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 046W1AN00650
• Device Lot Number: A1647209A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2012
• 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
• Patient Outcome(s): Other