MAUDE Adverse Event Report: TYBER MEDICAL 25BX20LX20R STERILE KIT; 25X20X20MM STAPLE KIT

Model Number 15ZB00111

Device Problems Material Fragmentation (1261); Insufficient Information (3190)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378); Skin Infection (4544)

Event Date 11/10/2023

Event Type  malfunction  

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 implicated lot met release requirements.Without further evidence, the root cause of this complaint is indeterminate.

Event 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.Patient trying a bone stimulator.

• Brand Name: 25BX20LX20R STERILE KIT
• Type of Device: 25X20X20MM 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: 18860051
• MDR Text Key: 337675261
• Report Number: 3012966183-2024-00003
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00196449009015
• UDI-Public: 00196449009015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15ZB00111
• Device Lot Number: 247603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male