MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI ROD 240MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	498.957
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional product codes: kwp, mni, mnh, nkg.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that a patient underwent c2-t2 posterior spinal fusion last (b)(6) 2012 with synthes 3.5 mm rod system.On an unknown date, patient broke both rods caudal to the c6 screws.The patient has a non-union at the area of the rod breakage.On (b)(6) 2018, a revision was performed.The surgeon elected to removed all the synapse 3.5mm rod hardware and replaced it with synapse 4.0mm rod system hardware.There were no other issues with the previous synapse 3.5mm rod hardware other than the rod breakage.The revision procedure was completed successfully.There was no surgical delay.Patient outcome is unknown.This report is for one (1) 3.5mm ti rod 240mm.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity# unknown).This complaint involves two (2) devices.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part: 498.957; lot: 6363301; date of manufacture: may 19, 2010; place of manufacture: j&b precision (brandywine); part expiration date: none; list of nonconformances: none.No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.No ncrs were generated for the device's raw materials.Review of the device history records for the devices' raw materials showed that there were no issues with the product's raw materials that would contribute to this complaint action.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.5MM TI ROD 240MM
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8043889
• Report Number: 2939274-2018-54871
• Device Sequence Number: 11088301
• Product Code: KWQ
• UDI-Device Identifier: 10705034792316
• UDI-Public: (01)10705034792316
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: 498.957
• Device Catalogue Number: 498.957
• Device Lot Number: 6363301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 12/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR