MAUDE Adverse Event Report: TYBER MEDICAL 7.5MM TI CANN SCREW + FT - 95MM

Model Number	04.355.895
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date reamer shafts were bent at the tip after reaming.Reamer heads would not snap on.Staple was used and released early whenever we tried to mallet staple gently while drilling line to line, 7.5 x 95 x 2 screws had no purchase and the tip seemed to break off while insertion.We did not predrill.Staple, and screws were not charged to patient and still implanted.There were 3 mins of surgical delay.There was no patient outcome.

• Brand Name: 7.5MM TI CANN SCREW + FT - 95MM
• 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: 18336802
• Report Number: 3012966183-2023-00030
• Device Sequence Number: 6787771
• Product Code: HWC
• UDI-Device Identifier: 00810040681219
• UDI-Public: 00810040681219
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/15/2023

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: 04.355.895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 12/15/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown