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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX STRATAFIX SPIRAL PGA-PCL 30 CM X 30 CM

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SURGICAL SPECIALTIES CORPORATION STRATAFIX STRATAFIX SPIRAL PGA-PCL 30 CM X 30 CM Back to Search Results
Model Number SXMD2B412
Device Problem Insufficient Information (3190)
Patient Problem Necrosis (1971)
Event Type  Injury  
Manufacturer Narrative
Method: the actual device was not available for evaluation. No photos or samples from the reported finished good lot were returned for testing or review. Results: no samples were returned for testing or review. Relevant portions of the device history record (dhr) and sterility record were reviewed. All components and finished good devices met current requirements for this size/type barbed suture device. Conclusion: necrosis of cells surrounding a wound most often occurs due to inadequate blood supply to the cells surrounding the area. Other complications can contribute to this as well, damage to tissues during the surgery, tight sutures; excessive tension on wound edges, expanding hematoma. A patients health status and/or post-operative conditions can also have an effect on healing, circulation and blood flow (moh''s patient, diabetic, cigarette smoker). Without receiving detailed information regarding the patient's health status, procedure performed, surgeon's technique, post-operative instructions and events that may have occurred post-operatively a definitive root cause cannot be determined at this time.
 
Event Description
It was reported that the knee was sutured with a size 3/0 pga/pcl barbed device. The patient presented with necrosis of the wound. No additional information was provided.
 
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Brand NameSTRATAFIX
Type of DeviceSTRATAFIX SPIRAL PGA-PCL 30 CM X 30 CM
Manufacturer (Section D)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000
24702-b ejido francisco villa
tijuana 22235
MX 22235
Manufacturer (Section G)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000
24702-b ejido francisco villa
tijuana 22235
MX 22235
Manufacturer Contact
kelly knappenberger
1100 berkshire blvd.
ste 308
reading, PA 19608
MDR Report Key7487841
MDR Text Key107385878
Report Number3010692967-2018-00008
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 04/10/2018,05/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSXMD2B412
Device Catalogue NumberSXMD2B412
Device Lot NumberAABT956
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date04/06/2018
Device Age7 MO
Event Location No Information
Date Report to Manufacturer04/10/2018
Date Manufacturer Received04/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2017
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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