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 patient had a scheduled revision for two broken rods at l5 and s1.Patient had pseudoarthrosis.During revision, the broken rods were removed and replaced.While bending the rod with in situ benders, the new rod broke.It was removed and replaced.Surgical delay of 10 minutes was reported.
Additional Manufacturer Narrative
(b)(4).The viper2 straight 300mm cocr rod was returned to the complaint handling unit (chu).The rod was returned in two separate pieces.One was approximately 10cm long and bent, ending with the normal end of the rod on one side and the fracture point at the other.The other piece was approximately 14cm long and mostly straight, ending with a cut mark on one side and the opposing side of the fracture at the other.The fracture marks on opposing sides of the rod line up with one another, showing that these are two segments of the same rod.Fracture analysis was performed on these returned sections.Optical imaging of the broken rods¿ surfaces two areas; a wide, rough but uniform section with sweeping progression lines across the majority of the surface ending with a raised, jagged end at the far side of the rod.This implies that the fracture initiated near one side of the rod¿s edge and then propagated through the body of the rod across its axial plane to full failure/breakage near the opposing side, presumably when the strength of the remaining material was insufficient to bear the load.The surface also exhibits minor scratches and smooth shiny areas indicative of surfaces rubbing against one another post-fracture.No material defects or other abnormalities were observed in this analysis.Hardness testing was not performed, as the available method for testing is intended for stainless steel instruments.However, this lot passed its certificate of conformance.A review of the device history record did not find any issues that could have caused or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review.The root cause of the rod breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a potential root cause may be fatigue failure.This may have occurred due to forces placed on the rod over an extended period of time resulting in the fracture first propagating across the rod and then full failure/breakage taking place when the strength of the remaining region did not have the strength to bear the load.As no issues could be identified in the manufacturing or release of this product.Therefore, this complaint will be closed with no further action required.

• 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: 8228312
• Report Number: 1526439-2019-51215
• Device Sequence Number: 1997061
• Product Code: NKB
• UDI-Device Identifier: 10705034295251
• UDI-Public: (01)10705034295251
• Combination Product (Y/N): N
• Initial Reporter State: GA
• PMA/510(K) Number: K090648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 12/14/2018

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: GM50354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/08/2019
• 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