MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCRDRIVER T8 SELF-HOLDING ANGL W/SLEEVE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	03.617.900
Medical Device Problem Codes	Mechanical Problem (1384); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the angled stardrive screwdriver threads that attach the angled zero pva driver to the unknown guide do not allow the screwdriver to rotate when tightened onto an unknown guide.The screwdriver can be advanced if you loosen the attachment knob a few turns.However, the screwdriver eventually disconnects from the unknown guide and it is unknown when the issue was discovered.This report is for one (1) scrdriver t8 self-holding angl w/sleeve.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.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 the reported issue was noticed during inspection.There was no patient or procedure involvement.
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.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images provided.The image was reviewed, and the complaint condition is not confirmed.There are no visual defects on the device in the provided photo that would contribute to the complaint condition.As the physical device was not received, it cannot be confirmed that the device is unable to be rotated while tightened.A definitive assignable root cause could not be determined based on the provided information.No dhr review was completed since no lot number was supplied via photo or additional information.The dhr will be revisited when the physical device is received.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) 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.No dhr review was completed since no lot number was supplied via photo or additional information.The dhr will be revisited when the physical device is 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.
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.H3, h6: a product investigation was conducted: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed, that scrdriver t8 self-holding angle w/sleeve was missing the sleeve and handle components.The attachment knob was scratched from use.No mating devices or other components were returned.Therefore, a functional test could not be performed.A dimensional inspection was unable to be performed, due to the definitive finding of a missing component.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed, as the observed condition of the scrdriver t8 self-holding angle w/sleeve would contribute to the complained device issue.There is no indication, that a design or manufacturing issue has caused the complaint condition.And hence, the root cause cannot be determined.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.The lot number is unknown.Therefore, no mre could be performed.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: SCRDRIVER T8 SELF-HOLDING ANGL W/SLEEVE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12885165
• Report Number: 2939274-2021-06847
• Device Sequence Number: 17388970
• Product Code: OVE
• UDI-Device Identifier: 10705034717142
• UDI-Public: (01)10705034717142
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2021

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: 03.617.900
• Device Catalogue Number: 03.617.900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021; 05/11/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 12/02/2021; 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDES/SLEEVES/AIMING: SPINE
• Patient Sex: Unknown