MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI HARD ROD 100MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	498.104
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2018
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: mni, kwp, kwq, nkb.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported on (b)(6) 2018, the patient underwent a revision surgery.The patient had a traumatic injury last (b)(6) 2017 with sacral and pelvic fractures.The patient had a bilateral lumbopelvic spine construction with synthes uss fracture at l5-ilium (no screws in sacrum).The patient broke the left rod just cranial to the left iliac screw on an unknown date.The surgeon then removed all the uss fracture hardware.There were no other hardware issues other than the broken left rod.The surgeon re-instrumented the patient with synthes uss screws in the existing screw holes at l5 and the ilium with the new rods in place.The procedure was completed successfully.Patient outcome is unknown.This complaint involves one (1) device.This report is 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.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
There was no patient consequence reported.Concomitant devices: clamps (part: unknown, lot: unknown, quantity: 1), schanz screw (part: unknown, lot: unknown, quantity: 1).
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.Additional narrative: dhr review was completed.Part number 498.104.Lot number: h197926.Date of manufacture: 11-16-16.Place of manufacture: brandywine plant.Part expiration date: n/a (nonsterile) the device history record(s) showed that there were no nonconformances or issues during the manufacture of the product that would contribute to this complaint condition 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.Corrected data: adverse event, product problem, required intervention.Date of device breakage is not known.Product code, common name.Additional product codes: mnh, mni, lwp, kwq.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 100MM
• 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: 7971292
• Report Number: 2939274-2018-54415
• Device Sequence Number: 11157740
• Product Code: NKB
• UDI-Device Identifier: 10705034788852
• UDI-Public: (01)10705034788852
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K090605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2018

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: 498.104
• Device Catalogue Number: 498.104
• Device Lot Number: H197926
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/17/2018; 11/14/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 10/18/2018; 11/19/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE EVENT DESCRIPTION
• Outcome Attributed to Adverse Event: Congenital Anomaly; Required Intervention
• Patient Age: 18 YR