MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT; SURGICAL NEEDLE

Catalog Number 216705

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Aspen surgical received a report from the end user indicating that a surgical needle broke during a procedure.All pieces were recovered.No injury/death was reported.This is entered in our system as (b)(4).

Manufacturer Narrative

Aspen surgical received a report from the end user indicating that the surgical needle broke while in use.The actual device was not returned for evaluation.The manufacturing lot number was provided for review.Photographic evidence was not provided for review.As no samples or pictures were provided, investigation was limited.However, based on similar previous complaints where samples were returned, it is suspected that user error in holding/clamping the needle may have caused the breakage.This should be treated as the final report, however if any additional relevant information is indentigied in the future, the additional relevant information will be submitted in a supplemental report.

• Brand Name: NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT
• Type of Device: SURGICAL NEEDLE
• 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: 18897399
• MDR Text Key: 337661863
• Report Number: 3002750084-2024-00009
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 216705
• Device Lot Number: 355130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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