MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 STRAIGHT ROD300MM, COCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	196789300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported: broken rod at l5 left / caused the revision (revision case took place (b)(6) 2018).Loose pedicle screw l5 right / caused the revision (revision case took place (b)(6) 2018).Broken pedicle screw s1 right / caused the revision (revision case took place (b)(6) 2018).Broken iliac screw right / caused the revision (revision case took place (b)(6) 2018).Loose pedicle screw l5 left / caused the revision (revision case took place (b)(6) 2018).Broken expedium polyaxial screwdriver / occurred during the revision surgery (b)(6) 2018.Broken power expedium / occurred during the revision surgery (b)(6) 2018.
Additional Manufacturer Narrative
(b)(4).A visual inspection confirmed the rod was broken in two.Fracture analysis of the broken pieces was conducted.Optical imaging of the fracture shows two surface morphologies, which is indicative of a fatigue load leading to ultimate 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 for the rod fracturing cannot be positively determined.However, the fracture analysis report exhibits two surface morphologies which are indicative of fatigue failure.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 ROD300MM, COCR
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8074504
• Report Number: 1526439-2018-51068
• Device Sequence Number: 13931562
• Product Code: NKB
• UDI-Device Identifier: 10705034295251
• UDI-Public: (01)10705034295251
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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
• Operator of Device: Health Professional
• Device Model Number: 196789300
• Device Catalogue Number: 196789300
• Device Lot Number: GM50065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention