MAUDE Adverse Event Report: TYBER MEDICAL 6.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 65MM; TRAUMA SCREW

Model Number	04.333.765
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted for an event that was identified as part of a historical data review comparing clinical trial adverse events with the vigilance system.The complaint was investigated without the affected device or specific lot information.The device was discarded, therefore a device evaluation could not be performed.Upon review of clinical records, a specified device malfunction could not be established.The device was removed from the patient as a result of an additional injury sustained after the patient had an accident.With the information provided from the clinical site and no device malfunction, the root cause of the event is traced to non-device related factors.
Event or Problem Description
From clinical investigation: at 19-months post-operative the subject slipped in the shower and presented to the clinic with a probable anterior talofibular ligament sprain with questionable symptomatic nonunion of the subtalar joint.The subject was placed back in a fracture boot during the visit.At 23.5 months post-operative a ct scan was obtained where nonunion was confirmed.The subject had the devices removed 23.5 months post-operative and replaced with other hardware.Subject was terminated from the study after hardware removal.

• Brand Name: 6.5MM TI CANN COMPRESSION HEADLESS SCREW- ST- 65MM
• Common Device Name: TRAUMA SCREW
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer Contact: tamara lewis ; 83 s commerce way; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 20486422
• Report Number: 3012966183-2024-00016
• Device Sequence Number: 3615552
• Product Code: HWC
• UDI-Device Identifier: 00819917025675
• UDI-Public: 00819917025675
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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: 04.333.765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 144 KG