MAUDE Adverse Event Report: DEPUY SYNTHES SPINE X25 HEXLOBE DRIVER; DRIVER, PROSTHESIS

Catalog Number 279712600

Device Problems Detachment Of Device Component (1104); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) a follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

During a posterior l3-5 fusion with expedium 5.5, we were setting up the instruments for the case.The tech was putting together a reduction sleeve (2797-12-580 lot#nw141996) when she noticed that the bottom portion became un-attached when she put the inner driver in.The bottom portion of the reduction sleeve is supposed to rotate while the sleeve is being threaded into the flex clip.Upon recognition, she set the instrument aside and was able to use the backup reduction sleeve to successfully complete the case with no patient harm.The broken instrument was found like this when we opened the pan and never made its way off the back table.When it came time to final tighten, we used the x25 torque driver (2797-12-600 lot#gm3771404).The l5 polyaxial screw head was pretty far lateral, therefore the surgeon had to battle against a considerable amount of muscle and skin to get the proper trajectory of the set screw to final tighten it.Amidst trying to get the right angle, he slipped off the set screw twice causing the flanges on the tip of the driver to distort.We didn't want to strip the set screw completely so we switched drivers to our backup shaft and completed the case successfully, final tightening all 6 set screws properly.There was no patient harm caused by this instrument.

Manufacturer Narrative

One (1) mmsi final tightener were returned to the complaint handling unit (chu) for evaluation.Visual examination revealed that the distal tip on the x25 torque driver product code: (b)(4), lot no: gm3771404) was stripped in the direction of tightening.This damage is consistent with a tightener that is inadequately engaged during use and, resulted due to unanticipated torsional forces during tightening.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.A definitive root cause cannot be determined for the x25 tightener distal tip stripping.However, the observed damage is localized to the distal tip of the tightener suggesting that it was inadequately engaged during use.An unanticipated torsional force during tightening in this position could have contributed to the reported problem of thread stripping.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: X25 HEXLOBE DRIVER
• Type of Device: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5438340
• MDR Text Key: 38820508
• Report Number: 1526439-2016-10130
• Device Sequence Number: 1
• Product Code: HWR
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 279712600
• Device Lot Number: GM3771404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2012
• 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