MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186731845
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with findings.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
A few years ago, plif surgery was performed using cannulated cortical fix screw 7 x 45mm (part#: 186731745, lot#: unk).The fixed area was l5 - s.On (b)(6) 2017, revision surgery was performed due to lumbar disc hernia (l3 - l5) and pseudarthrosis (l5 - s).For details of this revision, please refer to (b)(4).During the revision surgery, the following issues happened while the surgeon was inserting two cfs screws (part#: 186731845, lot#: avkdyf) to s1.The tip of the driver (part#: 286725020, lot#: ag2098256) got broken and was left in this cfs screw, however, the surgeon successfully removed the screw and the tip together by using si polyaxial driver (s1, right side).Similarly, the tip of the driver (part#: 279734000, lot#: mi34169) got broken and was left in this cfs screw.The surgeon tried to remove the broken tip, however, he could not remove it.Then, the screw head was removed from this cfs screw.The broken tip and screw shaft were left in the patient¿s bone (s1 left side).The surgery was completed with a 60-minute extension.No further information has been provided from the hospital.
Additional Manufacturer Narrative
It was observed at the start of analysis that the screw had its tulip completely separate from the screw shank.The saddle remains in place inside the tulip head.The tulip head, saddle, and screw head all remain in fair condition outside of some markings indicative of tool contact and stress placed on the screw during tightening.However, the flex ball had fractured and was in multiple pieces.The flex ball fracturing would allow the saddle/tulip head to separate from the screw 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.The root cause of the screw falling apart cannot be determined from the sample and the information provided.A potential root cause may be excessive force placed on the screw and its tulip head 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
• 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: 6954433
• Report Number: 1526439-2017-10848
• Device Sequence Number: 1228767
• Product Code: NKB
• UDI-Device Identifier: 10705034352190
• UDI-Public: (01)10705034352190
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 186731845
• Device Catalogue Number: 186731845
• Device Lot Number: AVKDYF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 11/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR