MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI ROD 80MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	04.615.525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, two (2) 5.5mm rods were noted to be not functioning during a reverse logistics audit of the returned devices at millstone.There was no patient involvement and no additional information is available.This report is for one 4.0mm ti rod 80mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
The initial complaint was reviewed and found not reportable.This event is not a complaint as the reported devices were parts from the field returned.They were tagged as broken but these were actually remnants of implants which were cut during the surgery.
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.H11: b1, b5, h1: the initial complaint was reviewed and found not reportable.This event is not a complaint as the reported devices were parts from the field returned.They were tagged as broken but these were actually remnants of implants which were cut during the surgery.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: 4.0MM TI ROD 80MM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9643879
• Report Number: 2939274-2020-00523
• Device Sequence Number: 19407026
• Product Code: NKG
• UDI-Device Identifier: 10705034740621
• UDI-Public: (01)10705034740621
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.615.525
• Device Catalogue Number: 04.615.525
• Device Lot Number: 9217846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/27/2020
• Patient Sequence Number: 1