MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI HARD ROD 200MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	498.108
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procodes: kwp, kwq, mnh, mni.Date of implantation is an unknown date in (b)(6) 2018.Complainant part is not expected to be returned for manufacturer review/investigation.Date of concomitant therapy is the same as date of implantation, an unknown date in (b)(6) 2018.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).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.
Event or Problem Description
It was reported that on (b)(6) 2019, the patient underwent revision due to broken left rod.The patient previously had a posterior spinal fusion extension with synthes universal spinal system (uss) in (b)(6) 2018.The synthes spine uss hardware extended non-synthes t10-s1 hardware to t7 using rod to rod connectors.The synthes uss screws were placed in t7-t11 and were connected to the older hardware caudal to the new construct.At an unknown point in time, the left synthes rod broke just caudal to the t11 screw.The surgeon removed the uss nuts, collars, and two (2) rods.He then replaced both of the rods with new rods of the same type.He also used the same connectors and completed the procedure.It is unknown if there was a surgical delay.There were no patient consequences.Concomitant devices: uss nuts (part: 498.003, lot: unknown, quantity: unknown), uss collars (part: 498.010, lot: unknown, quantity: unknown), uss rod (part: 498.108, lot: unknown, quantity: unknown), uss screws (part: unknown, lot: unknown, quantity: unknown).This report is for a 6.0mm titanium (ti) hard rod 200mm.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part: 498.108; lot: h244037; date of manufacture: february 15, 2017; place of manufacture: (b)(4).Supplier - (b)(4); 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/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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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: 6.0MM TI HARD ROD 200MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8529262
• Report Number: 2939274-2019-57552
• Device Sequence Number: 19300524
• Product Code: NKB
• UDI-Device Identifier: 10705034788883
• UDI-Public: (01)10705034788883
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K082572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 498.108
• Device Catalogue Number: 498.108
• Device Lot Number: H244037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention