MAUDE Adverse Event Report: TYBER MEDICAL T8 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN; SCREWDRIVER

Model Number	03.333.302
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Screwdriver did not fit into the screws during operation was surgery delayed due to the reported event? yes.Action taken when event occurred? an other scredriver was used.Was procedure successfully completed? yes.
Additional Manufacturer Narrative
Device was not received so physical evaluation was not possible.The lot number was not provided.Therefore, a review of the dhr could not be completed.Historical data review performed on this part number revealed 6 additional complaints within 36 months for unrelated issues.At the time of the investigation, there was no capa and no trends associated with this event type.The product was not returned.Therefore, it could the root cause could not be determined.Complaints similar to this are monitored through tracking and trending.

• Brand Name: T8 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 south commerce way; suite 310; bethlehem PA 18017
• Manufacturer Contact: jeff zoleta ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 17217781
• Report Number: 3012966183-2023-00011
• Device Sequence Number: 6214043
• Product Code: LXH
• UDI-Device Identifier: 00819917026870
• UDI-Public: 00819917026870
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.333.302
• Device Catalogue Number: 03.333.302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown