MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE; BARD-PARKER BLADE

Model Number 371110-150

Device Problem Break (1069)

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

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report indicating that blade broke during a procedure.No injury or death was reported.Item was in use at the end user.No sample or photographic evidence was available for evaluation.A manufacturing lot number was provided for review.Information from the end user noted that blade tip broke off scalpel while in use for skin incision.No surgical intervention was required to retrieve the broken piece and post operative x-ray confirmed that the broken tip was not in the patient.No adverse effect was reported for the patient.Device history record was reviewed and no non-conformance was issued that could be related to reported event.The most probable root cause could have been during the stamping or grinding process.Packaging process has established controls to mitigate broken or cracked blade condition, including a "medio" blade sensor that inspects 100% of packed pouches liner level prior to aluminum foil packaging.Also, excessive force applied by end user during surgery process could also cause blade condition.The following controls are in-place to mitigate "broken blade" condition at aspen surgical las piedras site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Based on this information, no additional actions required.Device not returned.

Event Description

Aspen surgical received a report indicating that a blade broke during a procedure.No injury or death was reported.Item was in use at the end user.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE
• Type of Device: BARD-PARKER BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 10540138
• MDR Text Key: 214813275
• Report Number: 1836161-2020-00041
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371110-150
• Device Lot Number: 0223350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• 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