MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	03.617.900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional product code: kwq.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.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.
Event or Problem Description
It was reported that on (b)(6) 2020, while the surgeon was implanting the titanium cervical spine screw, the angle stardrive screwdriver broke off the driver shaft.The broken stardrive screwdriver was removed in one piece from the surgical site.Fragments were generated from the broken device and were removed easily.Another driver was used to complete the procedure.There was no surgical delay.Procedure was successfully completed.There was no patient consequence.Concomitant device reported: titanium cervical spine screw (part number 04.647.836, lot unknown, quantity 1).This report involves one (1) angled stardrive screwdriver t8 with sleeve/self-retaining.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.H3, h6: the device has been 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.
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.The angled stardrive screwdriver t8 with sleeve/self-retaining (p/n: 03.617.900, lot number: unk) was received at us cq.Upon visual inspection, the tip has broken off and the holding sleeve is missing.A dimensional inspection could not be performed due to post-manufacturing damage and the definitive finding of a missing component.This complaint is confirmed as the tip of the device has broken off.Additionally, the holding sleeve component is missing.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10101391
• Report Number: 2939274-2020-02563
• Device Sequence Number: 3560951
• Product Code: OVE
• UDI-Device Identifier: 10705034717142
• UDI-Public: (01)10705034717142
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K152239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.617.900
• Device Catalogue Number: 03.617.900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 06/08/2020; 06/30/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 06/24/2020; 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.7MM TI CERVICAL SPINE SCREW; 3.7MM TI CERVICAL SPINE SCREW
• Patient Age: 28 YR