MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE POLYAXIAL SCREW 5.5MM X 7.00MM X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	188112740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Review of the device history record identified no issues during the manufacturing or release of the product that could be attributed to the problem reported by the customer.The product was released accomplishing all quality requirements.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
It was reported that the patient had fusion with implants approximately one year ago with unknown surgeon.Patient subsequently fell at work and when an xray was taken, it showed the shafts of both s1 screws bilaterally had sheared off from the head.Posterior hardware removal l5/s1 was performed.Because there was already bony fusion, all implants were removed without replacement.
Additional Manufacturer Narrative
Visual examination of the returned device revealed the shank was fractured off the screw head.Screw shank was not returned.Device was subsequently sent for fracture analysis.Optical imaging found two surface morphologies, a smooth region and a grainy/rough region with progression lines which are indicative of fatigue failure.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause cannot be positively determined from the sample and the information provided.However, based on the evaluation, the possible cause of the breakage is fatigue failure of the screw and inability of the screw to bear the load or the effect of the fall by the patient which will cause the shafts of the screw to break.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: POLYAXIAL SCREW 5.5MM X 7.00MM X 40MM
• 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: 6811014
• Report Number: 1526439-2017-10688
• Device Sequence Number: 19349472
• Product Code: NKB
• UDI-Device Identifier: 10705034146973
• UDI-Public: (01)10705034146973
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 188112740
• Device Catalogue Number: 188112740
• Device Lot Number: RL139406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 09/13/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention