MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE FAVORED C/C MINIPOLY SCREW 3.5 X 3.5 X 14MM (SUMT); ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	188318314
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2017
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 was performed using the mountaineer system.The fixed area was c3 ¿ t2.During the surgery, when the surgeon inserted the following screw to c3 (right), he noticed that the collet was dropped off.- favored angle screw 3.5 x 14 (part#: 188318314, lot#: armfv7).He did not pull out the driver smoothly, he tried to pull in and out the driver a couple of times.But he did not understand why this issue happened.He dealt with this event by replacing the screw in question with a new one.The surgery was successfully completed without any delay, and here was no adverse consequence to the patient.
Additional Manufacturer Narrative
Visual examination of the returned device found the inner saddle was dislodged from the tulip head.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 trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause cannot be positively determined.However, the observed damage suggests that unanticipated high amounts of force was placed on the tulip during use.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: FAVORED C/C MINIPOLY SCREW 3.5 X 3.5 X 14MM (SUMT)
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6821188
• Report Number: 1526439-2017-10700
• Device Sequence Number: 1511236
• Product Code: MNI
• UDI-Device Identifier: 10705034157184
• UDI-Public: (01)10705034157184
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151885
• 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): 08/04/2017

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: 188318314
• Device Catalogue Number: 188318314
• Device Lot Number: ARMFV7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 09/08/2017
• Patient Sequence Number: 1