MAUDE Adverse Event Report: DEPUY SYNTHES SPINE XPDM QUICK-CON SI POLY SCWDRVR; SCREWDRIVER

Catalog Number 279712400

Device Problems Bent (1059); Break (1069); Sticking (1597)

Patient Problem Not Applicable (3189)

Event Date 01/09/2008

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual examination at the macroscopic level revealed that the fracture was located at the driver¿s distal tip.The second half of the driver tip was not returned for analysis.An optical image of the fractured surface reveals plastic deformation at the hex lobes and torsional shear markings following a circular pattern.This suggests the fractured tip underwent a quasi-static overload torsional shear failure.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the fractured tip of the expedium si polyaxial driver cannot be determined.However, fracture analysis suggests that fractured tip underwent a quasi-static overload torsional shear failure.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 were found, 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.

Event Description

On (b)(6) 2018, the surgery for spinal canal stenosis was performed by using the expedium concorde system.The fixed area was l3 ¿ s.When the screw in question was inserted, the screw was stuck and did not move forward or backward in the middle since the vertebral body was hard, and the torque for screw insertion was strong.Because of that, while the surgeon was trying to remove the screw, the tip of two screw drivers in question was stripped, and the tip of one screw driver in question was broken.The broken tip of the screw driver in question had been left in the core part of the screw.Regarding the screw (cfs 8 x 50 mm) which was stuck in the middle, the surgeon tried to remove it in several ways after one of the screw drivers was broken.Since the same maneuver for removing the screw was done repeatedly, the head of the screw in question was broken, and the thread part of the screw in question was left in the patient.In order to remove the thread part of the screw in question, the 4.75 power grip rod holder in question was used.Although the surgeon tried to remove the screw thread, the tip of the rod holder was bent.As a result, the thread part of the screw in question could not be removed.By surgeon¿s medical judgement, the thread part of the screw was left in the patient, and then the procedure was completed with more than a 60-minute-delay.

• Brand Name: XPDM QUICK-CON SI POLY SCWDRVR
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 7285959
• MDR Text Key: 100936167
• Report Number: 1526439-2018-50153
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034198897
• UDI-Public: 10705034198897
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 279712400
• Device Lot Number: 1010MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Date Manufacturer Received: 02/14/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR