MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 3.5 ROD - 120MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	188316120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # = > (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
Patient had an occipital-c3 fusion in (b)(6) 2017.Patient's right side rod broke and needed replacing.Patient consequence? :yes.Patient consequence description: return to or for additional procedure.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
(b)(4).One mountaineer 3.5 mm ti rod [product code: 1883-16-120, lot no: unknown] was received for evaluation.Visual examination at the macroscopic level revealed that the rod had fractured in two pieces.Device was then sent for fracture analysis.The fracture analysis report exhibit two surface morphologies a smooth and a grainy/rough region and progression lines which are indicative of fatigue failure.No material defects or other abnormalities have been identified in the fracture analysis report.A review of the device history record could not be conducted as the lot number did not appear of the portion of rod that was returned.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the rod fracturing cannot be positively determined.However, the fracture analysis report exhibits two surface morphologies a smooth and a grainy/rough region and progression lines 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: 3.5 ROD - 120MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7195752
• Report Number: 1526439-2018-50044
• Device Sequence Number: 1447516
• Product Code: KWP
• UDI-Device Identifier: 10705034157054
• UDI-Public: 10705034157054
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2017

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: 188316120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 02/02/2018
• 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
• Patient Age: 17 YR
• Patient Weight: 61