MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE FAVORED M/L MINIPOLY SCREW 3.5 X 4.35 X 25MM(SUMT); ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	188319525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2017, surgery for spondylolisthesis was performed using the mountaineer system.The fixed area was c7 ¿ t1.The following issues are confirmed during the surgery.- the surgeon made the hole by using 4.0 mm tap.- he tried to insert the 4.35 mm screw using the screw driver (part#: 288304000), however, tip of the screw driver got broken and then the broken tip was buried inside the screw.- he attached the screw to the rod and set screw together, and then pulled the screw out.- eventually the screw got broken.There were no broken parts found left in the body and the surgery was successfully completed with a 30-minute delay.There was no adverse consequence to the patient.No further information has been provided.
Additional Manufacturer Narrative
Udi: (b)(4).Visual examination of the mountaineer screw revealed that a tip of the screw driver was stuck in its drive feature.No other issues were found.The investigation could not verify the reported compliant of screw being broken.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.Root cause cannot be determined.The investigation could not verify or identify any evidence of product contribution to the reported problem.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: FAVORED M/L MINIPOLY SCREW 3.5 X 4.35 X 25MM(SUMT)
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6839766
• Report Number: 1526439-2017-10727
• Device Sequence Number: 10964955
• Product Code: MNI
• UDI-Device Identifier: 10705034158044
• UDI-Public: (01)10705034158044
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2017

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: Physician
• Device Model Number: 188319525
• Device Catalogue Number: 188319525
• Device Lot Number: 124553
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 09/01/2017
• Supplement Report FDA Received Date: 10/06/2017
• Patient Sequence Number: 1