MAUDE Adverse Event Report: CONVENTUS FLOWER ORTHOPEDICS ZERO PROFILE INTERLOCKING CORTEX SCREW, 3.5MM X 60MM, T15, FLEX-THREAD¿; LOCKING SCREW

Model Number	8525-60-S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The event included the breakage of the head of a zero profile interlocking cortex screw during implantation.The affected screw shaft was left in the patient.
Additional Manufacturer Narrative
Dr.(b)(6) inserted this screw using the appropriately-sized screwdriver on power.Final tightening was completed using the handheld screwdriver.The breakage occurred during the last 1-2 turns, as the screw was seating itself into the bone.

• Brand Name: ZERO PROFILE INTERLOCKING CORTEX SCREW, 3.5MM X 60MM, T15, FLEX-THREAD¿
• Common Device Name: LOCKING SCREW
• Manufacturer (Section D): CONVENTUS FLOWER ORTHOPEDICS; 100 witmer rd.; ste 280; horsham PA 19044
• Manufacturer (Section G): ODYSSEY MEDICAL TECHNOLOGIES (CONTRACT MANUFAC.); 2975 brother blvd; barlett TN 38133
• Manufacturer Contact: amanda pentecost ; 100 witmer rd.; ste 280; horsham, PA 19044 ; 2153234029
• MDR Report Key: 12861757
• Report Number: 3009996260-2021-00014
• Device Sequence Number: 4351538
• Product Code: HSB
• UDI-Device Identifier: 00840118117050
• UDI-Public: 00840118117050
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202858
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: 8525-60-S
• Device Catalogue Number: 8525-60-S
• Device Lot Number: 2106321753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2021
• 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
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Hispanic