MAUDE Adverse Event Report: DEPUY SPINE INC EXP DI FAR QUICK CONNECTOR DVR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	279722890
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint : (b)(4).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
It was reported that the tip of instrument (b)(4) broke inside the screw head.The bone was very hard even though the surgeon tapped the whole before insertion.The screw was removed and replaced with another one.The tip of instrument (b)(4) got stripped during final tightening.Patient consequence? :no.
Additional Manufacturer Narrative
(b)(4).Visual examination at the macroscopic level found that the fracture was located at the driver¿s distal tip.A fracture analysis report was conducted on the returned device.It was noted plastic deformation at the hexlobes and torsional shear markings following a circular pattern.This plastic deformation at the hexlobes indicates a torsional overload.This suggests that the driver 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 quick-connect driver distal tip fracturing cannot be positively determined.However, as noted in the fracture analysis report it is suggested that the driver 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.

• Brand Name: EXP DI FAR QUICK CONNECTOR DVR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8090745
• Report Number: 1526439-2018-51088
• Device Sequence Number: 1225365
• Product Code: LXH
• UDI-Device Identifier: 10705034199450
• UDI-Public: (01)10705034199450
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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: 279722890
• Device Catalogue Number: 279722890
• Device Lot Number: 0408MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1