MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. HOFFEE SUTURE RETRIEVER 10 INCH STERILE

Model Number	710000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are attempting to obtain the device for evaluation, but have been unsuccessful so far.The investigation is ongoing.If any additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "the issue was that it wasn't strong enough to pull the suture through the tissue sometimes.In one case, the loop broke off in the patient where it couldn't be retrieved.".
Additional Manufacturer Narrative
The device was not returned for evaluation, no pictures were provided, and the lot of the device was not provided.In addtion, we were unable to obtain more details about the event.We could not confirm the compaint.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: HOFFEE SUTURE RETRIEVER 10 INCH STERILE
• Common Device Name: SUTURE RETRIEVER
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 21993773
• Report Number: 3002750084-2025-00017
• Device Sequence Number: 14574691
• Product Code: LXH
• UDI-Device Identifier: 00840113230518
• UDI-Public: 00840113230518
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 710000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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