MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX; 2FS-1 2-0 UND MONODERM 30X30

Model Number SXMD2B410

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem Wound Dehiscence (1154)

Event Type  malfunction  

Manufacturer Narrative

Method: the actual product involved with the incidents were discarded by the end user.No photos or samples were provided for review/testing.Results: no samples were returned for review.Relevant portions of the device history record could not be reviewed as the lot number reported does not match any lot in our system.Conclusion: without receiving the finished good lot number, samples to review/test, detailed information regarding the surgeon's technique, material placement in tissue, pre-operative preparation, and/or post-operative instructions or events a definitive root cause for the partial dehiscence cannot be determined with certainty.

Event Description

It was reported by the sales rep that the patient had a total hip procedure and the wound was closed with stratafix suture along the subcuticular layer of the skin.The patient returned, post-op, complaining about wound dehiscence along the skin closure.The doctor noticed the barbs of the suture weren't holding the tissue together and could be seen sliding back and forth after the suture was placed.The patient was treated with steristrips and released.Seven (7) cases reported.No patient specific information was provided.The exact date of event is unknown.

• Brand Name: STRATAFIX
• Type of Device: 2FS-1 2-0 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: 7194117
• MDR Text Key: 97894160
• Report Number: 3010692967-2018-00001
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• PMA/PMN Number: K051609
• 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: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: SXMD2B410
• Device Catalogue Number: SXMD2B410
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/20/2017
• Event Location: Imaging Center - Mobile
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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