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

Model Number	179712740
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.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
This was a revision surgery due to a re deco and screw breakage.Customer kindly asks us to investigate why the screw broke.Screw breakage s1 - previous surgery was on (b)(6).
Additional Manufacturer Narrative
(b)(4).The expedium single innie 7 x 40 mm polyaxial screw (product code: 1797-12-740, lot number: avkbl8) was returned to the customer quality unit (cqu) on november 1st, 2017.The screw was found to be broken at its neck.The screw was subsequently submitted for fracture analysis.Visual examination at the macroscopic level reveal that the fracture occurred at the transition between the screw shank sphere and the screw shank body.The proximal region of the screw shank body also reveals tool marks on the external threads; likely occurred during extraction from the patient after device failure.An optical image of the fractured surfaces on the shank sphere and shank body show evidence of fatigue progression across a smooth surface region.The fatigue propagated across this surface towards the suspected termination site where full failure / fracture occurred.No material defects or other abnormalities were observed in this analysis.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.No emerging trends were found requiring further actions.A root cause for the reported device becoming loosened cannot be positively determined.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 requiring immediate action have been observed, 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: EXPEDIUM SPINE
• 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: 6958653
• Report Number: 1526439-2017-10866
• Device Sequence Number: 745663
• Product Code: NKB
• UDI-Device Identifier: 10705034067896
• UDI-Public: (01)10705034067896
• 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 Implanted Year: 2017
• 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: 179712740
• Device Catalogue Number: 179712740
• Device Lot Number: AVKBL8
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 11/16/2017
• 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
• Patient Age: 82 YR
• Patient Weight: 67