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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 Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/26/2019
Event Type  Injury  
Manufacturer Narrative
Aspen surgical received a report indicating that a bard-parker blade detached while in use during a procedure. The incident occurred at the user facility. No manufacturing lot number or sample were provided for review. End user indicated that following a left shoulder arthroscopy, the surgical blade was retained in the patient's left shoulder for several days post discharge. The patient experienced post op discomfort and was evaluated in the emergency room and discharged. Several days later, patient was seen by the surgeon for post op visit where x-rays were obtained and noted the retained blade. The retained blade was surgically retrieved successfully. No further patient follow up required. Due to no manufacturing lot number provided, a review of the device history record could not be completed. The most probable root cause could be contributing to blade detached from handle condition where the handle could be damaged. However, this could not be verified due to no return in sample. Additionally, excessive force applied by the end user during surgery process could contribute to the condition. The following controls are in-place to mitigate blade detached from handle 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. No sample was available for return. Based on this information, no further action is required.
 
Event Description
Aspen surgical received a report from the distributor indicating that a bard-parker blade detached during a procedure. Incident occurred at the end user. 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 Key8633251
MDR Text Key145838698
Report Number1836161-2019-00040
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 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number371111-150
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 Received04/26/2019
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

Patient Treatment Data
Date Received: 05/22/2019 Patient Sequence Number: 1
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