MAUDE Adverse Event Report: TYBER MEDICAL 3.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 40MM

Model Number 04.334.340TS

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 01/06/2023

Event Type  Injury  

Event Description

Toe fusion completed on the (b)(6) 2022 at (b)(6) hospital.Patient presented with broken screw and a non-union of the fusion.

Manufacturer Narrative

The device lot met the release requirements and no non-conformances were identified.There are 0 complaints associated with the device part number, and 0 complaints associated with the device lot.At the time of the investigation, there was no capa and no trends associated with this event type.This event did not have a product return for evaluation.Xrays were provided which confirm the implant had fractured in two pieces.To determine a root cause further information would be required, specifically: when did it actually break? was there any follow up imaging completed post op? was there any bone growth/fusion viewed post op? when was the patient weight bearing / walking? what was the post operative protocol? was the patient compliant to the post operative protocol? what is the patient's gender/weight/age/comorbidities/risk factors? without further information, a root cause cannot be determined.Information from the complainant was requested in order to complete the requirements for the information that was requested by the country of incident reportable agency but no further information was received from the complainant.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.

Manufacturer Narrative

The device lot met the release requirements and no non-conformances were identified.There are 0 complaints associated with the device part number, and 0 complaints associated with the device lot.At the time of the investigation, there was no capa and no trends associated with this event type.This event did not have a product return for evaluation.Xrays were provided which confirm the implant had fractured in two pieces.To determine a root cause further information would be required, specifically: when did it actually break? was there any follow up imaging completed post op? was there any bone growth/fusion viewed post op? when was the patient weight bearing/walking? what was the post operative protocol? was the patient compliant to the post operative protocol? what is the patient's gender/weight/age/comorbidities/risk factors? without further information, a root cause cannot be determined.Information from the complainant was requested in order to complete the requirements for the information that was requested by the country of incident reportable agency but no further information was received from the complainant.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.The complaint device was returned via rma 22091 and received 2-23-2023.The returned device was observed from outside the packaging and was confirmed to be fractured.The package was not opened to remove the device as there was foreign matter in the packaging with the device that appeared to be human tissue.The subject device was observed to be fractured from inside the packaging, thus confirming the complaint event.However, there was foreign matter inside the packaging that appeared to be human tissue and therefore the device was not further evaluated.See the previous complaint investigation for further investigation details.The root cause still cannot be established and further information is required to determine a root cause.

Event Description

Toe fusion completed on the (b)(6) 2022 at (b)(6) hospital.Patient presented with broken screw and a non union of the fusion.

• Brand Name: 3.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 40MM
• Type of Device: HEADLESS 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: jeff zoleta ; 83 south commerce way; suite 310; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 16294215
• MDR Text Key: 308751600
• Report Number: 3012966183-2023-00001
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133842
• 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,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.334.340TS
• Device Catalogue Number: 04.334.340TS
• Device Lot Number: 234334
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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