MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE; BLADE, SCALPEL

Model Number 371211-150

Device Problem Break (1069)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

Aspen surgical received a report from the distributor indicating that a scalpel blade broke during a procedure.No injury/death was reported.This event was filed in our compliant handling system as number (b)(4).

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that a scalpel blade broke during a knee arthroscopy procedure.The actual device was not returned for evaluation.The manufacturing lot number was provided for review.Photographic evidence was provided for review as well.If any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.

• Brand Name: BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE
• Type of Device: BLADE, SCALPEL
• 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: 18269578
• MDR Text Key: 329751126
• Report Number: 1836161-2023-00046
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2023

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
• Device Operator: Health Professional
• Device Model Number: 371211-150
• Device Lot Number: 220613KF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/05/2023
• 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