MAUDE Adverse Event Report: TYBER MEDICAL 3.0MM TI CANN COMPRESSION HEADLESS SCREW- ST- 26MM

Model Number	04.333.226TS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Performed an ipj fusion using cchs.This instrument set used was the set on the shelf that contained the reusable 2.0mm drill bit (310.221).When drilling for the screw the drill bit broke into pieces.Bits were removed as best as possible and fresh drill bit was used from another kit.Screw was inserted successfully.On final x- rays there was not visible remnants of the broken drill bit.When guide wire was removed it was identified to have a slight bend to it.If other, describe ipj fusion left side, was surgery delayed due to the reported event? yes, if yes, number of minutes: 30 minutes, action taken when event occurred? metal items were removed , was procedure successfully completed? yes, were fragments generated? yes, if yes, were they removed easily without additional intervention? no, if no, explain: items were removed using various instruments.As mentioned on final x-ray no fragments were visible, patient status/ outcome / consequences no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe extra time and x-rays using fluoroscopy were needed, is the patient part of a clinical study no, ip(b)(4) device property of other, device in possession of bin 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.2.0mm drill bit (310.221) is not a tyber medical part number new info from surgeon: patient seen by dr.Fisher.Screw has migrated slightly and drill bit fragment identified.Dr fisher stated that the patient was currently happy and would see him again in 4 weeks.If revision surgery is happy dr fisher will remove drill fragment at that time.If not, he has stated that he will leave it where it is.
Additional Manufacturer Narrative
The complaint event though not a tyber medical device issue is reportable per the surgical delay of 30 minutes.The delay caused a wound delay of healing.Part number 310.221 is not a tyber medical device which fractured and caused the complaint event.

• Brand Name: 3.0MM TI CANN COMPRESSION HEADLESS SCREW- ST- 26MM
• Common Device Name: SCREW
• 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: tamara lewis ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 18160464
• Report Number: 3012966183-2023-00024
• Device Sequence Number: 12581568
• Product Code: HWC
• UDI-Device Identifier: 00819917027495
• UDI-Public: 00819917027495
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K192975
• 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): 11/17/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.333.226TS
• Device Lot Number: 224165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male