MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number	186727840
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Cfx 8.0 mm screw dismantled while implanting in l5 right level of patient.The cfx screw was almost totally screwed down into the pedicle bone when the ball-joint ruptured leaving the screw head totally away from the thread.Head and debris of ruptured ball-joint where immediately removed with no damage to the patient.The cfx screw thread was quite easy removed with help of exp.Viper rescue screw-driver.Another cfx was immediately inserted with no problem.
Additional Manufacturer Narrative
Visual examination of the returned revealed the tulip head and saddle had completely separated from the screw shank.The flex ball was not returned.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.The root cause of the flex ball breaking and the tulip head, saddle, and screw head separating cannot be determined from the samples and the information provided.A potential root cause may be unanticipated force placed on the polyaxial screw during tightening.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: VIPER SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6952497
• Report Number: 1526439-2017-10845
• Device Sequence Number: 1208632
• Product Code: MNI
• UDI-Device Identifier: 10705034282770
• UDI-Public: 10705034282770
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160879
• 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): 09/27/2017

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 Catalogue Number: 186727840
• Device Lot Number: ARKDV5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 65