MAUDE Adverse Event Report: PEGA MEDICAL INC THE FREE GLIDING SCFE SCREW SYSTEM; MINI FEMALE COMPONENT 48/50MM, Ø6.5MM

Model Number	SCF-T65-48S/50L
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The scf-m73-l was mistakenly put in a box labeled for an scf-t65-48s/50l during the preparation of the customer order.
Event or Problem Description
During the replenishment of a tray by the distributor, the box labeled for a scf-t65-48s/50l component was found with a scf- m73-l component instead.

• Brand Name: THE FREE GLIDING SCFE SCREW SYSTEM
• Common Device Name: MINI FEMALE COMPONENT 48/50MM, Ø6.5MM
• Manufacturer (Section D): PEGA MEDICAL INC; 1111 autoroute chomedey; laval, quebec H7W5J 8; CA H7W5J8
• Manufacturer (Section G): PEGA MEDICAL INC; 1111 autoroute chomedey; laval, quebec H7W5J 8; CA H7W5J8
• Manufacturer Contact: enrique garcia ; 1111 autoroute chomedey; laval, quebec H7W5J-8 ; CA H7W5J8
• MDR Report Key: 15304925
• Report Number: 3000327445-2022-00003
• Device Sequence Number: 12340755
• Product Code: HWC
• UDI-Device Identifier: 07540194002266
• UDI-Public: (01)07540194002266(10)B103-07
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K041393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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 Model Number: SCF-T65-48S/50L
• Device Catalogue Number: SCF-T65-48S/50L
• Device Lot Number: B103-07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2022
• 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 Sex: Unknown