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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.102 STERILE SURGICAL NEEDLE

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ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.102 STERILE SURGICAL NEEDLE Back to Search Results
Model Number 216705
Device Problem Break (1069)
Patient Problems Foreign Body In Patient (2687); No Information (3190)
Event Date 11/29/2017
Event Type  Injury  
Manufacturer Narrative
Aspen surgical performed a follow-up with the customer. The actual device was determined to be available for evaluation. The manufacturing lot number was also provided for review. The end user indicated that during a shoulder surgery, the eye section of the needle separated from the needle. Using x-ray guidance the surgeon was able to located and retrieve the detached eye section of the needle. Surgery time was prolonged. The patient tolerated well and follow up care was not required. Analysis result of the finished good lot number and incoming inspections of the raw material were reviewed. All samples passed acceptance criteria. No non-conformance's were noted in the dhr. Four needles were returned from lot 108328. Three needles were broken at the eye of the needle. One needle was intact. The broken needles have clamp marks around the needles closest to the eye and point. The unbroken needle does not have any marks on it. According to aspen surgical's ifu, the needles should not be clamped directly on the eye of the needle to the point and should be applied to the flat portion of the needle about 1/4 of the needle length from the eye end. A review of the samples returned show that the needles were clamped improperly either not on the flat side or too close to the eye or point, which likely caused them to break. Based on this information, the root cause is attributed to customer misuse and no further action is required.
 
Event Description
Aspen surgical received a report from the end user indicating that the eye of a 1/2 circle taper point needle separated during a procedure. This report was filed in our complaint handling system as complaint #(b)(4).
 
Event Description
During shoulder surgery, a piece of item number 216705 broke from the needle.
 
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Brand NameNEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.102 STERILE
Type of DeviceSURGICAL NEEDLE
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 Key7137706
MDR Text Key120547568
Report Number1836161-2017-00135
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number216705
Device Lot Number108328
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2016
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: 12/21/2017 Patient Sequence Number: 1
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