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

Model Number	04.334.240
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of the investigation, there was no capa and no trends associated with this event type.The product has not been returned for evaluation, and therefore cannot be evaluated.The lot number was not provided, therefore a dhr review 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
It was reported that on (b)(6) 2021, the surgeon is performing a hand case using our cannulated compression headless screws.The head of one of the screws broken off during the surgery the rest of the screw remains inside the finger and then discarded the head of the screw into the garbage while talking to the physician we think it was stuck in an unknown k-wire and being entered and force putting the screw on top of the screw.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.Concomitant device reported: unk - guide/compression/k-wires: (part# unknown; lot# unknown; quantity: 1) this complaint involves an unknown number of devices.

• 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: 11392443
• Report Number: 3012966183-2021-00005
• Device Sequence Number: 1165617
• Product Code: HWC
• UDI-Device Identifier: 00819917023749
• UDI-Public: 00819917023749
• Combination Product (Y/N): N
• PMA/510(K) Number: K133842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• 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: 04.334.240
• Device Catalogue Number: 04.334.240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• 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: Other
• Patient Age: 31 YR