MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 STRAIGHT ROD480MM, COCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 196789480

Device Problem Break (1069)

Patient Problem Spinal Column Injury (2081)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4)-unknown.Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported, the primary surgery was performed on (b)(6) 2018 to fix l5-s1 by using 2 rods (p/n: 196789480, lot number were gm46538 and gm46535).After the primary surgery, the surgeon found (on unknown date) under x-ray that the rod inserted to left side of l5-s1 (p/n: 196789480, lot number was gm46538 or gm46535) was broken, and the screw (p/n:199725745s, inserted to left side of s1) was also broken and separated into two pieces.The revision surgery was performed on (b)(6) 2018 and was completed by revising the rods and the screw.The patient is under monitoring now.No further information was provided by the hospital.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).An analysis was performed to investigate the fracture of the rod.Fracture analysis of the rod suggests that surfaces show highly irregularly shaped faces from either ductile failure and/or in vivo fretting.Surfaces also display apparent damage to the fracture surface and external threads consistent with tool marks inflicted during rod removal post fracture.The fractured surfaces also exhibit minor scratches and smooth shiny areas indicative of two surfaces rubbing against one another post-fracture.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause of the rod being broken post-operatively cannot be determined from the sample and the information provided.However, fracture analysis of the broken rod surface suggests ductile failure and/or in vivo fretting.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: VIPER2 STRAIGHT ROD480MM, COCR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7975299
• MDR Text Key: 124023008
• Report Number: 1526439-2018-50987
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034295275
• UDI-Public: (01)10705034295275
• Combination Product (y/n): N
• PMA/PMN Number: K090648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2018

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
• Device Operator: Health Professional
• Device Model Number: 196789480
• Device Catalogue Number: 196789480
• Device Lot Number: GM46538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 10/24/2018; 11/09/2018
• Supplement Dates FDA Received: 11/02/2018; 11/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 120