MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X.984 STERILE; NEEDLE, SUTURING, DISPOSABLE

Model Number 216706

Device Problem Break (1069)

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

Event Date 07/31/2023

Event Type  malfunction  

Event Description

Aspen surgical received a report indicating that a multiple needles broke during multiple procedures.Incident occurred at the end user.Multiple requests for more information were not answered, so we moved ahead based on the information we have received.This event was filed in our complaint handling system as (b)(4).

Manufacturer Narrative

Aspen surgical received a report stating that multiple needles broke during multiple procedures.Multiple requests for additional details went unanswered, so aspen moved ahead based on the information we have received.The actual device was not returned for evaluation.The manufacturing lot number was provided for review.I any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.

• Brand Name: NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X.984 STERILE
• Type of Device: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: terry hall ; 6945 southbelt dr; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 17711621
• MDR Text Key: 322970635
• Report Number: 1836161-2023-00030
• 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
• Type of Report: Initial
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 216706
• Device Lot Number: 335935
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2023
• 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