MAUDE Adverse Event Report: DEPUY SPINE INC XPDM QUICK-CON DI POLY SCWDRVR; SCREWDRIVER

Model Number	279722400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The original plif procedure was performed to stabilize l4-5 approximately three years ago.It was reported that this was a revision procedure (plif) treating spinal stenosis to stabilize l3-s on (b)(6) 2019.After inserting a screw on the right l5, the surgeon moved on to screw insertion on the left l5 with the screwdriver (279722400).The screw gradually did not go deeper.Replacing a ratchet handle did not correct the issue.When the surgeon detached a qc driver from the unit, it was found that the screwdriver¿s tip had broken off at the screw¿s core section.The screw, stuck with the fragment, was removed from the patient¿s body.The surgeon completed the procedure with a replacing screw less than a 30-minute surgical delay.Not much load was put during the screw¿s insertion.No further information is available.Concomitant devices reported: unknown screw, (part# unknown, lot# unknown, quantity# unknown) this complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint #: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual examination at the microscopic level revealed that the fracture was located at the driver¿s distal tip.The second half of the driver¿s tip was not returned.The fracture analysis report reveals plastic deformation at the hex lobes and torsional shear markings following a circular pattern.This suggests the fracture 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.A definitive root cause for the driver¿s distal tip becoming fractured cannot be positively determined.However, the fracture analysis report suggests that the 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, 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: XPDM QUICK-CON DI POLY SCWDRVR
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8920654
• Report Number: 1526439-2019-52019
• Device Sequence Number: 19469995
• Product Code: HXX
• UDI-Device Identifier: 10705034199344
• UDI-Public: (01)10705034199344
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 279722400
• Device Catalogue Number: 279722400
• Device Lot Number: MI60388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 09/09/2019; 11/01/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 10/01/2019; 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1