MAUDE Adverse Event Report: ARTHREX, INC. APS II SHVR HANDP,FT-SWCH CNTRL; POWERED SURG ORTHOPEDIC INSTR

Model Number	APS II SHVR HANDP,FT-SWCH CNTRL
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(shp cable) the evaluation confirmed the reported event, "it was reported that the device has cuts in the cable.There was no harm for the patient, operator or third party reported." and attributed to normal wear and tear due to the age of the device.
Event or Problem Description
It was reported that the device has cuts in the cable.There was no harm for the patient, operator or third party reported.No further information received.

• Brand Name: APS II SHVR HANDP,FT-SWCH CNTRL
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17974834
• Report Number: 1220246-2023-08271
• Device Sequence Number: 11379355
• Product Code: HWE
• UDI-Device Identifier: 00888867043220
• UDI-Public: 00888867043220
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K932699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

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: APS II SHVR HANDP,FT-SWCH CNTRL
• Device Catalogue Number: AR-8330F
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown