MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX; STRATAFIX SXMD2B150 3/0 UND MONODERM 30X30

Model Number SXMD2B150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

Method-the actual device was discarded by the end user.Samples from the reported lot were not returned for testing/review.A sample that was retained with the device history record was reviewed.Results/conclusion-a retained sample from the same lot was reviewed and photographed.The sample was barbed and met all current requirements for this size/type barbed suture device.Relevant portions of the device history record were reviewed.The finished good devices and all components met current usp and ssm requirements throughout the incoming inspection, manufacturing and final inspection processes.No inventory is available of the reported finished good lot.The retained sample was barbed per current requirements.Without receiving detailed information regarding the procedure, suture placement, technique utilized by the surgeon, patient specific health status, post-operative instructions or events a definitive root cause for the reported dehiscence cannot be confirmed at this time.

Event Description

It was reported by the distributor that during an unknown orthopedic procedure the surgeon noted little to no barbs on the stratafix device.The device was utilized and the fascia / skin layer was closed without incident.However, later (post-operatively) the surgeon learned of a wound dehiscence.No additional details regarding the patient's health status or other patient specific information was obtained.Detailed information regarding the procedure, surgeon's technique, post-operative events that may have induced the dehiscence or type of medical intervention provided were not disclosed.

• Brand Name: STRATAFIX
• Type of Device: STRATAFIX SXMD2B150 3/0 UND MONODERM 30X30
• 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 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: kelly knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 7292177
• MDR Text Key: 100794950
• Report Number: 3010692967-2018-00003
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• PMA/PMN Number: K072028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2018,02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/16/2022
• Device Model Number: SXMD2B150
• Device Lot Number: AABL220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/24/2018
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2018
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2017
• 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
• Patient Outcome(s): Required Intervention