MAUDE Adverse Event Report: TYBER MEDICAL 2.5MM TI CANN SCREW + ST - 26MM; 2.5MM TITANIUM CANNULATED HEADED SCREW - 26MM

Model Number	04.353.126
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The adverse event clinical surgeon ((b)(6)) stated that the cause of death is not related to the study device or surgical procedure.
Event or Problem Description
Retrospective clinical study: patient passed away unexpectedly in her home 11 days post operative.The adverse event form states this was not in relation to the study device or the surgical procedure, but the actual cause of death was not provided.
Event or Problem Description
Updated after further investigation, provided by user facility: patient presented to ed with a right tri malleolar ankle fracture & large posterior fragment which occurred during an mva.Patient was stable and received medical clearance prior to proceeding with surgery.Posterior malleolus fracture was addressed first which was reduced and plated in an anti-glide technique with a synthes posterior plate.The fibula was then plated using a synthes fibular plate, alignment and length were maintained.Second incision over the medial malleolus was made where 2 2.5mm synthes cannulated screws were placed to fix the anterior colliculus fragment.After addressing the fractures, repair was confirmed on fluoroscopic imaging and all wounds were irrigated and had vancomycin powder placed in them.Patient was placed in a sugar tong splint and was transferred to pacu after surgery in stable condition.There were no surgical delays or changes from pre-op indication for surgery.Strategy and approach for surgery stayed the same throughout.All fracture sites were clearly indicated on preop imaging.Patient's post-op behavior was normal.Proper pain management and dvt prophylaxis was provided.Discharged from hospital 2 days post-op to rehab facility with clearance from ortho & hospitalist.All implants were used for on label indicated use of fracture repair.Per note in emr, patient found unresponsive in bed at rehab facility.Failed to resuscitate patient, cause of death deemed to be natural.

• Brand Name: 2.5MM TI CANN SCREW + ST - 26MM
• Common Device Name: 2.5MM TITANIUM CANNULATED HEADED SCREW - 26MM
• Manufacturer (Section D): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer (Section G): TYBER MEDICAL; 83 s commerce way; bethlehem PA 18017
• Manufacturer Contact: tamara lewis ; 83 s commerce way; bethlehem, PA 18017 ; 8667610933
• MDR Report Key: 19059941
• Report Number: 3012966183-2024-00007
• Device Sequence Number: 5897620
• Product Code: HWC
• UDI-Device Identifier: 00810040630774
• UDI-Public: 00810040630774
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: 04.353.126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SYNTHES FIBULAR PLATE.; SYNTHES POSTERIOR PLATE.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White