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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 Foreign Body In Patient (2687)
Event Date 03/04/2019
Event Type  Injury  
Manufacturer Narrative
Aspen surgical received a report indicating that a bard-parker blade broke while in use during a procedure. The incident occurred at the user facility. A manufacturing lot number was provided for review. End user indicated that the blade broke inside the knee of the patient during a knee arthroscopy procedure which included synovitis of right post total knee. Blade broke at the time the surgeon was making his punctures with the blade and required intervention to retrieve it. Once the blade broke, the surgeon used a long grasper to retrieve the broken piece without opening the knee. Retrieval of the piece was successful and the procedure continued as intended. No adverse outcome to the patient. A review of the device history record was completed and no non-conformance's related to the reported issue were identified. The most probable root cause could have been machine related 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 the end user during surgery process could cause blade breakage. 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. No sample was available for return. Based on this information, no further action is required. Device not returned.
 
Event Description
Aspen surgical received a report from the end user indicating that a bard-parker blade broke during a procedure. 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 Key8468966
MDR Text Key140439723
Report Number1836161-2019-00030
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number371111-150
Device Lot Number0176970
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2018
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: 04/01/2019 Patient Sequence Number: 1
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