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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE Back to Search Results
Model Number 371211
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/26/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
We were notified of a complaint from a customer stating that during a procedure, the blade broke inside a patient¿s knee. The surgeon made a larger incision in order to be able to remove the blade. The patient is fine.
 
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Brand NameBARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE
Type of DeviceBARD-PARKER STAINLESS STEEL BLADES SIZE 11
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer Contact
bradley liske
6945 southbelt dr. s.e.
caledonia, MI 49316
MDR Report Key6349196
MDR Text Key68280742
Report Number1836161-2017-00008
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 01/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371211
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2017
Was Device Evaluated by Manufacturer? Yes
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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