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

Model Number	FHT 200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of 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.A review of the lot was conducted and found no non-conformances associated with this specific complaint type.The lot met release requirements.Complaints of this nature are monitored through tracking and trending.If a trend is detected, further investigation will be conducted throught he capa/continuous improvement process.Not further action is required at this time.(b)(4).
Event or Problem Description
"in a phone call on (b)(6) 2021, (b)(6) noted that two implants broke during dr.(b)(6) case.The first broken implant was described as snapping when it was being screwed in, specifically at the head of the implant where "it's connected to where it's broached." this implant was disposed of and a new implant was effectively used.The second implant also broke is a similar location when trying to screw in the implant.(b)(6) also noted that the implant tip appeared broken.However, the metal threading was described as also "unraveling" and "disintegrating." this metal threading came off of the implant and was lodged in the patient.The doctor made an incision near the implant site and was able to successfully remove the metal threading without using x-ray.The doctor was frustrated due to the two events and ended up using k-wires for fixation as an alternative.It was noted that the surgery time increased from 1.5-2 h to 3.5-4 h due to the two events.However, the patient was noted to have no adverse events as of their follow-up visit on (b)(6) 2021.Dr.(b)(6) described the implants as being very "delicate" and recommended creating a more flexible implant design.".

• Brand Name: FLOWERTOE CANNULATED
• Common Device Name: BONE COMPRESSION SCREW
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; suite 310; bethlehem PA 18017
• MDR Report Key: 11445543
• Report Number: 3012966183-2021-00008
• Device Sequence Number: 3539678
• Product Code: HWC
• UDI-Device Identifier: 00840118114035
• UDI-Public: 00840118114035
• Combination Product (Y/N): N
• PMA/510(K) Number: K170571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/09/2021

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 Expiration Date: 01/09/2024
• Device Model Number: FHT 200
• Device Catalogue Number: FHT 200
• Device Lot Number: 158501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/09/2021
• 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: Required Intervention