MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INNER SHAFT FOR REMOVAL SCREWDRIVER; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Model Number	03.647.972
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device received.Occupation: synthes rep.A review of the device history record: device history lot: part: 03.647.972, lot: 8589088.Manufacturing site: (b)(4).Release to warehouse date: 09.Sep.2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Background: it was reported on (b)(6) 2019, during evaluation at the loaner department, an inner shaft removal screwdriver was noted to have broken tip.There was no surgical procedure and patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the inner shaft for removal screwdriver (p/n 03.647.972, lot 8589088) was received with the threaded distal tip portion broken off and missing.The non-threaded distal tip portion was observed to be bent.No other issues were identified with the returned components of the device.The device failure/defect of broken and bent tip was identified during the investigation.Dimensional inspection: drawing: inner drive removal front se.Feature: non-threaded distal tip diameter.Result: conforming: dimensional inspection of the threads could not be conducted as the threaded distal tip is broken off and missing.The remaining thread form does not provide an accurate measurement for any thread diameters.Document/specification review: the following drawings, reflecting the manufactured and current revision, were reviewed.Inner-drive removal complete se_229522 rev c to d.Innerdrive removal front se_229482 rev c.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the inner shaft for removal screwdriver (p/n 03.647.972, lot 8589088) as the threaded distal tip portion was broken off and missing.The non-threaded distal tip portion was also observed to be bent.While no definitive root cause could be determined for the condition of the device, it is possible that the device encountered unintended/excessive forces, leading to bending and breakage of the distal tip.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 on (b)(6) 2019, during evaluation at the loaner department, an inner shaft removal screwdriver tip was discovered broken.There was no surgical procedure and patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: INNER SHAFT FOR REMOVAL SCREWDRIVER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8818192
• Report Number: 2939274-2019-59322
• Device Sequence Number: 11606379
• Product Code: OVE
• UDI-Device Identifier: 10705034720807
• UDI-Public: (01)10705034720807
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K112068
• 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
• Report Date (Section B): 06/27/2019

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: 03.647.972
• Device Catalogue Number: 03.647.972
• Device Lot Number: 8589088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1