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 Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2020
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) 2020, the patient underwent an open reduction internal fixation (orif) of metacarpal 3, 4, 5 due to a mal-union + non-union from the previous pinning.During the procedure, one (1) titanium cannulated compression headless screw broke during insertion into the 4th metacarpal.The head portion of the screw stuck on the screwdriver for removal.The surgeon used screw removal conical tool + needle holder to break off sections of the screw shaft.Half of the screw was removed with difficulty and the other half of the screw remained inside the 4th metacarpal.The procedure was continued by placing an alternate plate to fix fracture around the broken screw segment.One (1) cortex screw self-tapping head broke off during insertion.The screw head remained on the screwdriver and the screw shaft was removed easily with needle holder.Two (2) stardrive screwdriver shaft self retaining hex coupling was stripped on screw insertion and one (1) stardrive screwdriver shaft self retaining hex coupling broke on screw insertion.All parts of the broken stardrive screwdriver shaft self retaining hex coupling were easily removed.The procedure was successfully completed with a thirty (30) minute surgical delay.The patient outcome is unknown.Concomitant device reported: unknown plate (part# unknown, lot# unknown, quantity# unknown) this complaint involves five (5) 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
• MDR Report Key: 10101291
• Report Number: 3012966183-2020-00004
• Device Sequence Number: 2471915
• Product Code: HWC
• UDI-Device Identifier: 00819917023749
• UDI-Public: 00819917023749
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2020

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: 05/22/2020
• Initial Report FDA Received Date: 05/29/2020
• 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: Required Intervention
• Patient Age: 28 YR