MAUDE Adverse Event Report: TYBER MEDICAL 4.0MM TI CANN COMPRESSION HEADLESS SCREW- LT- 40MM

Model Number	04.334.440
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, during intra-op at the time of orif medial epicondyle the headless screw broke off in patient on insertion.There was a surgical delay of twenty (20) minutes.The action was taken as used broken screw removal set to retrieve broken half of the screw.Inserted another screw.Procedure was completed successfully.There were fragments generated.The fragment was difficult to remove, and we had to use broken screw instruments to retrieve the piece.This part took approximately 20 min.There was no patient consequences.There was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required which is screw removal process, larger incision, more bone removal, increased time in surgery, increased tourniquet time.This complaint involves one (1) device.
Additional Manufacturer Narrative
Device was not returned; therefore, a device evaluation was not performed.There were no photos provided to evaluate or additional imaging.No additional information provided by the complainant to assist with an evaluation of the complaint.A device history record review demonstrated one additional complaint for an unrelated issue.There was an in-process quality control non-conformance during 100% inspection where they scrapped 1 part.There are no additional non-conformances and there were no capas related to this part number.Since there is no information, imaging or device to evaluate the root cause is indeterminate.

• Brand Name: 4.0MM TI CANN COMPRESSION HEADLESS SCREW- LT- 40MM
• Common Device Name: 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: 16796439
• Report Number: 3012966183-2023-00006
• Device Sequence Number: 20427504
• Product Code: HWC
• UDI-Device Identifier: 00819917024395
• UDI-Public: 00819917024395
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K133842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

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: 04.334.440
• Device Catalogue Number: 04.334.440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 16 YR
• Patient Sex: Male