MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC 360 DEGREE SCALPEL HANDLE

Model Number	K360
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure which included use of a 360 degree scalpel handle, part of the handle detached and the patient obtained a cut.
Additional Manufacturer Narrative
Hu-friedy has contacted the customer to obtain additional information regarding the reported event and requested the device to be returned for evaluation.The investigation into the reported event is in process; a follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Based on the investigation performed by hu-friedy, the tip of the 360 degree scalpel handle separated due to production personnel over buffing the handle during the press fitting process.The device subject of the event was returned to hu-friedy.

• Brand Name: 360 DEGREE SCALPEL HANDLE
• Common Device Name: SCALPEL HANDLE
• 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: 15008798
• Report Number: 1416605-2022-00008
• Device Sequence Number: 2414551
• Product Code: GDZ
• UDI-Device Identifier: 10889950014193
• UDI-Public: 10889950014193
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/13/2022

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: K360
• Device Catalogue Number: K360
• Device Lot Number: 0322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 06/23/2022; 06/26/2023; 06/26/2023
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/26/2022; 08/01/2023; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown