MAUDE Adverse Event Report: SURGICAL SPECIALTIES PUERTO RICO INC.DBA ANGIOTECH STRATAFIX; PSL 0 MONODERM 60CM

Model Number SXMD1B102

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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

No samples were received for review or testing.A review of the device history record and sterilization records for this particular lot confirmed there were no quality issues noted and the devices met all specified requirements for this size/type barbed suture device.Without receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, surgeon's technique, post-operative instructions or events that may have occurred and/or contributed to the reports of infection/skin reactions, a definitive root cause cannot be determined at this time.

Event Description

There were four (4) patients that had total knee replacement surgeries and were found to have infections.Two (2) patients presented with superficial infection on the skin surface.One (1) presented with deep wound infection and one (1) with a patella fracture with superficial infection on the skin surface.Three (3) were re-operated and one (1) was treated conservatively with medication.No additional details could be obtained.This particular device was utilized to close the fat/subcutaneous layer.

• Brand Name: STRATAFIX
• Type of Device: PSL 0 MONODERM 60CM
• Manufacturer (Section D): SURGICAL SPECIALTIES PUERTO RICO INC.DBA ANGIOTECH; km 0.2, bo. ensenada; rincon 00677
• Manufacturer (Section G): SURGICAL SPECIALTIES PUERTO RICO INC.DBA ANGIOTECH; km 0.2, bo. ensenadak; rincon 00677
• Manufacturer Contact: kelly knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 7795818
• MDR Text Key: 117566874
• Report Number: 3010692967-2018-00016
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): Y
• PMA/PMN Number: K072028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,08/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: SXMD1B102
• Device Catalogue Number: SXMD1B102
• Device Lot Number: MDVR570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 06/13/2018
• Device Age: 17 MO
• Event Location: Home
• Date Report to Manufacturer: 07/19/2018
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention