MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI TRANSVERSE BAR WITH 5.0MM CLAMP; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	406.106
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: kwp, mnh, mni.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Without a lot number, the device history records review could not be completed as no product was received.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 an unknown date, during routine incoming inspection at field stocking location (fsl), it was discovered that the titanium transverse bar with clamp was broken.There was no patient involvement.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.Reporter is a synthes employee.Part: 406.106; synthes lot: 9957655; supplier lot: na; release to warehouse date: december 10, 2015; manufactured by synthes brandywine.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 this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: visual inspection performed at customer quality observed that the returned transverse bar was missing a screw(sub-component).There is nothing broken off the returned transverse bar.However, the complaint can be confirmed since its missing the sub-component.Drawing and document review: a manufacturing record evaluation was performed for the finished device lot number, that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Dimensional inspection: due to the nature of the complaint and missing component, dimensional inspection could not be performed.Conclusion: while no definitive root cause could be determined, it is possible that the device encountered unintended forces such as being dropped during usage, or handling, or any unintended misplacement of components during sterilization cycles could have contributed to this missing component complaint condition.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 TRANSVERSE BAR WITH 5.0MM CLAMP
• 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: 8750966
• Report Number: 2939274-2019-58959
• Device Sequence Number: 1669011
• Product Code: NKG
• UDI-Device Identifier: 10705034779379
• UDI-Public: (01)10705034779379
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K14283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: 406.106
• Device Catalogue Number: 406.106
• Device Lot Number: 9957655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1