MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS NEEDLE 1/2 CIRCLE TROCAR POINT MAYO CATGUT .050X 1.535 STERILE; SURGICAL NEEDLE

Model Number 217003

Device Problem Break (1069)

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

Event Date 07/07/2023

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the customer 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.If any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.

Event Description

Aspen surgical received a report from the customer indicating that a surgical needle broke while in use.No injury/death was reported.This event was filed in our compliant handling system as (b)(4).

Manufacturer Narrative

Aspen surgical received a report from a customer 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.If any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.The 3rd acknowledgement for report# 1836161-2023-00023 was never received.Therefore we are submitting again as a follow up to be sure that the reports were recieved.

Event Description

Aspen surgical received a report from the customer indicating that a surgical needle broke while in use.No injury or death was reported.This event was filed in our complaint handling system as # (b)(4).

• Brand Name: NEEDLE 1/2 CIRCLE TROCAR POINT MAYO CATGUT .050X 1.535 STERILE
• Type of Device: SURGICAL NEEDLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS; 6945 south belt drive se; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: stephanie sullivan ; 6945 south belt drive se; caledonia, MI 49316 ; 6165367557
• MDR Report Key: 17380207
• MDR Text Key: 319848952
• Report Number: 1836161-2023-00023
• 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,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 217003
• Device Lot Number: 274133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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