MAUDE Adverse Event Report: TYBER MEDICAL 15BX15LX18R STERILE KIT; 15X15X18MM STAPLE KIT

Model Number	15ZB00117
Medical Device Problem Codes	Material Fragmentation (1261); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378); Skin Infection (4544)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photographic evidence and x-ray show the malfunction of the device and irritation of the skin.A historical data review was conducted and returned no nonconformities, complaints, or capas in relation to the nature of the complaint for this part number have been conducted or detected.The lot met release requirements.Without further evidence, the root cause of this complaint is indeterminate.
Event or Problem Description
Hardware broke after the 6-8 weeks post op.Staple failed to unionize bone post op.Skin irritation only where large staples were implanted.Device still implanted and scheduling a revision to remove implicated device.

• Brand Name: 15BX15LX18R STERILE KIT
• Common Device Name: 15X15X18MM STAPLE KIT
• 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: 18859852
• Report Number: 3012966183-2024-00002
• Device Sequence Number: 3314028
• Product Code: JDR
• UDI-Device Identifier: 00196449009039
• UDI-Public: 00196449009039
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K221947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15ZB00117
• Device Lot Number: 246727
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2023
• 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 Sex: Female