MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SI POLYAXIAL SCREW DRIVER; SCREWDRIVER

Catalog Number 279712150

Device Problem Torn Material (3024)

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

Event Date 09/30/2015

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

One level degenerative surgery.4 expedium screws have been placed.After radiographic control, one screw had to be repositioned.The screwdriver 2797-12-150 has been used to remove the 6x50mm screw.During this process, the tread of the screwdriver detached from the instrument and the screw couldn't be removed with that instrument anymore.In the same surgery a pedicle probe (2797-02-030) was used and surgeons complaint about the instrument being bended.

Manufacturer Narrative

The driver shaft was not returned for evaluation.A review of the device history record could not be conducted as the lot number is unknown.There were not related complaints for this issue.The root cause is unknown as the device was not evaluated.No issues could be identified in the manufacturing or release of these products as no lots have been identified.No trends exist for driver tips tearing.Therefore, this complaint will be closed with no further action required.If more information and/or the complaint samples become available at a later date, the complaint will be reopened and the products will be evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not returned for evaluation.

Manufacturer Narrative

(b)(4).One (1) driver shaft for single innie screws (product code: 2797-12-150, lot number: 0609nt) was returned to the complaints handling unit (chu) for evaluation.Visual examination of the driver shaft revealed that the threads were stripped and peeled off.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 driver shaft (2797-12-150) thread stripping.However, the observed damage might be due to the inadequate engagement of the shaft and the screw resulting in the cross threading.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 requiredif information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SI POLYAXIAL SCREW DRIVER
• Type of Device: SCREWDRIVER
• 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: 5229855
• MDR Text Key: 31390107
• Report Number: 1526439-2015-10943
• Device Sequence Number: 1
• Product Code: HXX
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 279712150
• Device Lot Number: 0609NT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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