MAUDE Adverse Event Report: TYBER MEDICAL T6 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN; SCREWDRIVER

Model Number	03.333.300
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The screwdriver reference 03.333.300 of the cchs 2.0 technique does not anchor in the head of the screw reference 04.333.030ts with lot number 215913 at the time of surgery.We do not know if it is a problem with the screw or the screwdriver.Customer reference/po/service: (b)(6), was surgery.Delayed due to the reported event? yes, if yes, number of minutes: 60.Action taken when event occurred? cambio de técnica quirúrgica.Was procedure successfully completed? no.Were fragments generated? no.If yes, were they removed easily without additional intervention? unknown.If no, explain: no había más unidades de la referencia del tornillo requerida.Patient status/ outcome / consequences.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study?: no.Ip-01469889 device property of: other.Device in possession of: (b)(6).By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.This complaint involves one (1) device.

• Brand Name: T6 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: mark schenk ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 15122778
• Report Number: 3012966183-2022-00026
• Device Sequence Number: 12162958
• Product Code: LXH
• UDI-Device Identifier: 00819917026856
• UDI-Public: 00819917026856
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/28/2022

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: 03.333.300
• Device Catalogue Number: 03.333.300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/28/2022
• 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