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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE BARD-PARKER BLADE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE BARD-PARKER BLADE Back to Search Results
Model Number 371111-150
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 01/05/2021
Event Type  Injury  
Manufacturer Narrative
Aspen surgical received a report from the distributor indicated that a blade broke during a procedure at the end user. No sample or photographic evidence was available for evaluation. A manufacturing lot number was provided for review. Customer reported that the blade broke off in the patients shoulder into several pieces. The pieces of the blade were retrieved using a grasper. All pieces were retrieved successfully with no impact to the patients stability. The procedure was completed without further incident. A review of the device history record was completed. No non-conformance's relating to the reported issue were identified. 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 available.
 
Event Description
Aspen surgical received a report indicating that a blade broke during a procedure. Item was in use at the end user. This report was filed in our complaint handling system as complaint #(b)(4).
 
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Brand NameBARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE
Type of DeviceBARD-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 Key11258419
MDR Text Key229612850
Report Number1836161-2021-00005
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number371111-150
Device Lot Number0222854
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/05/2021
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 Treatment Data
Date Received: 02/01/2021 Patient Sequence Number: 1
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