MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 5.5 EXP VERSE FEN SCR 6.0X50; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number	199723650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the 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
L3/5 plf revision surgery planned for (b)(6) 2017 (remove/replace broken right l5 screw, dr (b)(6), private hospital.Primary implant date (b)(6) 2017.Report came through of a broken screw in situ.Right l5 screw.Id: (b)(4), female patient (b)(6).
Additional Manufacturer Narrative
(b)(4).Visual examination at the macroscopic level reveal that the fracture occurred along the shank body.The proximal region of the screw shank body also reveals tool marks on the external threads.Device was then sent for fracture analysis.The fracture analysis report reveals evidence of fatigue progression lines across the surface towards the suspected termination site where full failure / fracture occurred.No material defects or other abnormalities were observed.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.A definitive root cause for the polyaxial screw fracturing cannot be positively determined.However, the fracture analysis report reveals evidence of fatigue progression lines across the surface towards the suspected termination site where full failure / fracture occurred.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.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X50
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7105248
• Report Number: 1526439-2017-50053
• Device Sequence Number: 1933370
• Product Code: MNI
• UDI-Device Identifier: 10705034403076
• UDI-Public: 10705034403076
• Combination Product (Y/N): N
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2017

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: Health Professional
• Device Catalogue Number: 199723650
• Device Lot Number: 111616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/18/2018; 01/18/2018; 02/01/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/23/2018; 01/23/2018; 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention