MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. RICHARD ALLEN MAYO STYLE NEEDLE; NEEDLE, SUTURING, DISPOSABLE

Model Number	216704
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent subacromial decompression repair of right rotator cuff.At closing count scrub tech identified that one of the free needles had lost its tip.A right shoulder x-ray was performed and it was identified that a small linear metallic foreign body was in the region of the articula capsule of the right shoulder.

• Brand Name: RICHARD ALLEN MAYO STYLE NEEDLE
• Common Device Name: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr. se; caledonia MI 49316
• MDR Report Key: 16618548
• Report Number: MW5115989
• Device Sequence Number: 6148990
• Product Code: GAB
• UDI-Device Identifier: 00840113217588
• UDI-Public: (01)00840113217588
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/24/2023

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: 216704
• Device Lot Number: 294554
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White