MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE DUAL INNER POLYAXIAL SCREW 5.5 X 6.00 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179722645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Lot unknown.Awaiting sample: 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.Device not yet returned for evaluation.
Event or Problem Description
Intraoperatively breakage of screw head while insert the rod.
Additional Manufacturer Narrative
Visual examination of the returned found the inner cap had dislodged from it's intended position.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 head during insertion.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: DUAL INNER POLYAXIAL SCREW 5.5 X 6.00 X 45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6804672
• Report Number: 1526439-2017-10685
• Device Sequence Number: 1852746
• Product Code: NKB
• UDI-Device Identifier: 10705034070636
• UDI-Public: (01)10705034070636
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111136
• 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): 07/28/2017

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: 179722645
• Device Catalogue Number: 179722645
• Device Lot Number: ALGDN4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 10/03/2017
• Patient Sequence Number: 1