MAUDE Adverse Event Report: TYBER MEDICAL 7.5MM TI CANN SCREW +FT - 95MM

Model Number	04.355.895
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023 during pelvic surgery intraoperatively the head of a 7.5mmx95mm fully threaded css+ screw broke off in the patient.Surgery was successfully completed with a surgical delay of 45 minutes.This complaint involves one(1) device.
Additional Manufacturer Narrative
The device was not returned for evaluation, therefore an evaluation was not performed.No photographical evidence or further information provided to collaborate the complaint event.A historical data review was performed.A total of 1 complaint has been received for this device part number.There have been no capas related to this part number.Since there has been no further information provided by the complainant or evidence to support the complaint event a determination of the root cause is not possible.The device in question was not returned and therefore not evaluated.The root cause is indeterminate.No lot information was provided by the complainant, so a device history record review was not performed.

• Brand Name: 7.5MM TI CANN SCREW +FT - 95MM
• 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: 17171875
• Report Number: 3012966183-2023-00009
• Device Sequence Number: 7200603
• Product Code: HWC
• UDI-Device Identifier: 00810040681219
• UDI-Public: 00810040681219
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K133842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

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: 04.355.895
• Device Catalogue Number: 04.355.895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown