MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC NONABSORBABLE POLYPROPYLENE SUTURE

Model Number	PSN8385P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a dental procedure the needle on the psn8385p suture broke; the components of the broken needle were retrieved immediately.It was observed that the patient had cuts on the inside of their cheek around the suture area.The patient was treated with oracort (dental paste).
Additional Manufacturer Narrative
The device subject of the event was not returned for evaluation.A sample of sutures from the same box at the user facility was evaluated and no issues were noted.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: NONABSORBABLE POLYPROPYLENE SUTURE
• Common Device Name: NONABSORBABLE POLYPROPYLENE SUTURE
• Manufacturer (Section D): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer (Section G): HU-FRIEDY MFG. CO. LLC; 3232 n rockwell st.; chicago IL 60618
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16113187
• Report Number: 1416605-2023-00001
• Device Sequence Number: 5753882
• Product Code: GAW
• UDI-Device Identifier: 10889950001872
• UDI-Public: 10889950001872
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/06/2023

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: PSN8385P
• Device Catalogue Number: PSN8385P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 01/06/2023
• 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
• Patient Sex: Unknown