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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES STRATAFIX SUTURE; 2CTX #2 PDO 36 X 36

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SURGICAL SPECIALTIES STRATAFIX SUTURE; 2CTX #2 PDO 36 X 36 Back to Search Results
Model Number SXPD2B405
Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2020
Event Type  malfunction  
Manufacturer Narrative
To date a lot number has not been provided and therefore we are unable to perform a lot review to determine if there were any non-conformances reports with this issue.The needle is an ethicon component.No samples were returned for testing or review.There were no retained samples available for testing.Ethicon third party summary has not been received to date.The bending, fracturing, breaking of a needle can occur when needles are gripped with a needle holder, forceps, surgical instrument on or near the swaged area or near the tip of the device, when excessive force is applied, when the device(s) are used in applications involving tortuous tissue or with a needle tip design that may not be appropriate for the specific tissue or procedure.Without reviewing the actual broken needle, receiving magnified photos of the broken device or results from the third party analysis, testing sterile devices from the same finished good lot or receiving details regarding the tools utilized to grasp the needle component, procedure performed or the surgeon¿s technique a definitive root cause cannot be determined at this time.
 
Event Description
It was reported by the sales rep that during an orthopedic procedure the tip of the needle broke off and fell into the patient.Via xray it was located and then retrieved delaying the case.A new device was used to complete the case with no patient consequences.No device will be returned.
 
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Brand Name
STRATAFIX SUTURE
Type of Device
2CTX #2 PDO 36 X 36
Manufacturer (Section D)
SURGICAL SPECIALTIES
corredor tijuana rosarito 2000
#24702 b, ejido francisco vill
tijuana
MX 
Manufacturer (Section G)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000 #24702b
ejido francisco villa
tijuana 22235
MX   22235
Manufacturer Contact
ronald giannangelo
247 station drive
suite ne1
westwood, MA 02090
MDR Report Key10684649
MDR Text Key213454083
Report Number3010692967-2020-00034
Device Sequence Number1
Product Code NEW
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K080985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/29/2020,10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSXPD2B405
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/25/2020
Event Location Hospital
Date Report to Manufacturer09/29/2020
Initial Date Manufacturer Received 09/29/2020
Initial Date FDA Received10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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