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

Model Number PSN8385P

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event 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).

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
• Type of Device: 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
• MDR Text Key: 308589157
• Report Number: 1416605-2023-00001
• Device Sequence Number: 1
• Product Code: GAW
• UDI-Device Identifier: 10889950001872
• UDI-Public: 10889950001872
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PSN8385P
• Device Catalogue Number: PSN8385P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1