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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 10, STERILE; BARD-PARKER BLADE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER STAINLESS STEEL BLADES SIZE 10, STERILE; BARD-PARKER BLADE Back to Search Results
Model Number 371210-150
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/14/2022
Event Type  Injury  
Manufacturer Narrative
Aspen surgical received a report from the distributor indicating that a blade broke during a procedure.The incident occurred at the end user.According the report, the surgeon noticed the blade was not intact when he returned the instrument to the surgical tech.The blade piece was then successfully retrieved from the patient by the surgeon.A review of the device history record was completed.No non-conformance's were noted during the device history record review.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 from a distributor indicating that a blade broke during a procedure.The incident occurred at the end user.The issue was filed in our complaint handling system under number (b)(4).
 
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Brand Name
BARD-PARKER STAINLESS STEEL BLADES SIZE 10, STERILE
Type of Device
BARD-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 Key15509779
MDR Text Key300894486
Report Number1836161-2022-00025
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 Other
Type of Report Initial
Report Date 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number371210-150
Device Lot Number0255252
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/30/2022
Initial Date FDA Received09/30/2022
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 Sequence Number1
Patient Outcome(s) Required Intervention; Other;
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