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

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.

• Brand Name: STRATAFIX
• Type of Device: STRATAFIX 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 Key: 7487841
• MDR Text Key: 107385878
• Report Number: 3010692967-2018-00008
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2018,05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2022
• Device Model Number: SXMD2B412
• Device Catalogue Number: SXMD2B412
• Device Lot Number: AABT956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/06/2018
• Device Age: 7 MO
• Date Report to Manufacturer: 04/10/2018
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1