MAUDE Adverse Event Report: FLOWER ORTHOPEDICS DBA CONVENTUS FLOWER ORTHOPEDIC VARIABLE ANGLE LOCKING SCREW; SCREW, FIXATION, BONE

Model Number	FRP 318
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was initiated on (b)(6) 2022 for an expired implant (frp 318 000 screw) that was implanted (expiry date 2022-04).

• Brand Name: VARIABLE ANGLE LOCKING SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): FLOWER ORTHOPEDICS DBA CONVENTUS FLOWER ORTHOPEDIC; 100 witmer rd; ste 280; horsham PA 19090
• Manufacturer (Section G): FLOWER ORTHOPEDICS DBA CONVENTUS FLOWER ORTHOPEDIC; 100 witmer rd; ste 280; horsham PA 19090
• Manufacturer Contact: amber thomas ; 100 witmer rd; ste 280; horsham, PA 19090
• MDR Report Key: 15501137
• Report Number: 3009996260-2022-00004
• Device Sequence Number: 5415685
• Product Code: HWC
• UDI-Device Identifier: 00840118100830
• UDI-Public: 00840118100830
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/28/2022

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: 04/01/2022
• Device Model Number: FRP 318
• Device Lot Number: 2015000963
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/29/2022
• 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: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female