MAUDE Adverse Event Report: TYBER MEDICAL CANNULATED COMPRESSION HEADLESS SCREW; BONE COMPRESSION SCREW

Model Number	04.334.655
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.However, x-ray images as well as patient history, both pre- and post-operatively, have been provided and evaluated.Based on the information provided, it can be determined that there were no issues with the screws used in the procedure.The procedure was attempting to correct a severe deformity in a large individual and the surgeon noted that it was expected that something could fail in this complicated procedure.The lot number was not provided, and therefore a review of the lot could not be performed.Complaints of this nature are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.No further action is required at this time.(b)(4).
Event or Problem Description
Joint fusion/arthrodesis of the intermediate talus on the left side using a 5.5mm headless titanium screw 55mm long (with long thread), a 5.5mm headless titanium screw 60mm long (with long thread), a 6.5mm headless titanium screw 100mm long (with short thread) and a 7.5mm headless titanium screw 90mm long (with short thread) with proteios non-structural allograft.Patient had severe deformity that required a complicated treatment.The treatment resulted in a pseudarthrosis/nonunion with screw breakage (the two 5.5mm diameter screws) that required revision by a tibial calcaneal fusion with a nail.The two intact screws were removed, but the broken screws were left in the patient due to the difficulty of removing them, and per the surgeon were not required to be removed.

• Brand Name: CANNULATED COMPRESSION HEADLESS SCREW
• Common Device Name: BONE COMPRESSION SCREW
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; suite 310; bethlehem PA 18017
• MDR Report Key: 11391869
• Report Number: 3012966183-2021-00003
• Device Sequence Number: 11054084
• Product Code: HWC
• UDI-Device Identifier: 00819917025484
• UDI-Public: 00819917025484
• Combination Product (Y/N): N
• PMA/510(K) Number: K133842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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: 04.334.655
• Device Catalogue Number: 04.334.655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR