MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION TORQUE HANDLE; CORAL

Catalog Number 10-40-0122

Device Problems Malposition of Device (2616); Material Deformation (2976); Noise, Audible (3273)

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

Event Date 05/18/2014

Event Type  malfunction  

Event Description

It was reported the torque limiting handle makes a funny noise but clicks over, over torqued screws.Additional information was received in direct conversation with the reporter on 04-jun-2014- 'during a posterior fusion thoracic/lumbar surgery, the torque limiting handle over torqued about 90 lbs and splayed the screws and cross threaded the caps.The surgery time was delayed 5 - 10 minutes.There was no injury or adverse consequence to the patient.The surgeon reported that he noticed the issue when the final tightening was done with the torque limiting handle (pn 10-40-0122).The surgeon noticed an unusual noise while applying the torque but the torque limiting handle stick clicked over; the surgeon noticed the heads of the screws had splayed and the caps had been cross threaded.Concomitant devices used in this surgery pn 10-17-0001-locking screw assembly, pn 18-40-0250 counter torque instrument.

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: TORQUE HANDLE
• Type of Device: CORAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; cincinnati OH 45227
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3957479
• MDR Text Key: 4560699
• Report Number: 3004608878-2014-00093
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10-40-0122
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKING SCREW ASSEMBLY, 10-17-0001; COUNTER TORQUE INSTRUMENT, 18-40-0250