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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 SURGICAL BLADE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE SURGICAL BLADE Back to Search Results
Model Number 371111-150
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 05/01/2017
Event Type  malfunction  
Manufacturer Narrative
The most probable root cause is the stamping or grinding process; however, the customer provided an incorrect lot date and was unable to return the sample for evaluation. 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. 100% visual inspection by certified personnel is performed to segregate nonconforming material, including broken blades, prior to assembly and packaging process. Each associate performing 100% inspection process is certified and re-certified on an annual basis on blade defect criterias. Capa (b)(4) was initiated to evaluate current controls in place corrective actions identified were completed and capa closed on 10/26/15. New capa (b)(4) was initiated for the broken blade defect.
 
Event Description
Broken blade, no injury reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Broken blade, no injury reported.
 
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Brand NameBARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE
Type of DeviceSURGICAL BLADE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer (Section G)
SAME AS ABOVE
Manufacturer Contact
megan morrissey
6945 southbelt dr. s.e.
caledonia, MI 49316
MDR Report Key6582153
MDR Text Key250954092
Report Number1836161-2017-00049
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,Followup
Report Date 09/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371111-150
Device Lot Number411035
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2017
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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