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U.S. Department of Health and Human Services

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

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD PARKER CARBON STEEL RIB BACK BLADES SIZE 11 BARD-PARKER BLADE Back to Search Results
Model Number 371111
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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 not provided for review. End user reported that the patient was undergoing a shoulder arthroscopy procedure and when the surgeon was trying to make the first cut the blade broke in half. The blade did fall on to the surgical field, however there was no surgical opening at the time. The blade was picked up from the field and a new blade was retrieved without further incident. There was no report of any adverse patient consequence or effect on the patient's stability as a result of the incident. There was no serious injury, follow-up medical care, or medical intervention reported related to this event. The actual sample involved in the incident is not available to be returned for evaluation. Due to no lot number available, a review of the device history record could not be completed. 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. Sample not available for return. No additional information is available on the product. No further action required.
 
Event Description
Aspen surgical received a report from the distributor indicating that a bard-parker blade broke during a procedure. Incident occurred at the user facility. No injury/death reported. This report was filed in our complaint handling system as complaint # (b)(4).
 
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Brand NameBARD PARKER CARBON STEEL RIB BACK BLADES SIZE 11
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 Key9306134
MDR Text Key175239902
Report Number1836161-2019-00089
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 10/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371111
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 Received10/15/2019
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

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