MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX; STRATAFIX SXPD2B202 20S-8 #2 PDO 36 X 36

Model Number SXPD2B202

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

Method-the actual devices were discarded by the end user.Samples from the reported lot were not returned for testing/review.A sample was retained with the device history record.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 a total knee procedure the surgeon noted little to no barbs on four (4) (b)(4) devices.The devices were utilized and the fascia layer was closed without incident.However, later (post-operatively) the surgeon learned of wound dehiscence.No additional details regarding the patient's health status or other patient specific information was obtained.Detailed information regarding the surgeon's technique, post-operative events that may have induced the dehiscence or type of medical intervention provided were not disclosed.

Manufacturer Narrative

Four (4) unopened samples and one (1) opened sample of item (b)(4) from finished good lot aabr631 were received at the (b)(4).A visual inspection was performed on the opened sample.Barbs were observed on the device, however they appeared shallow.A dimensional inspection was performed on the unopened samples.All of the devices measured below the acceptance criteria.The same samples were sent to the manufacturing site in (b)(4).The devices were measured and the barb depth measurements were also confirmed below the acceptance value specified for this size suture.The root cause for the barbs measuring below the specified criteria is attributable to the barb cutting process.In-process inspection/measurements are currently performed every thirty (30) units to assure adequate barb depth.A corrective /preventive action, (b)(4) was initiated at the tijuana facility.

Manufacturer Narrative

On 2/19/18, four (4) unopened samples and one (1) open sample of item sxpd2b202 from finished good lot aabr631 were received at the (b)(4) facility premises.A visual inspection was performed of the open sample and it had barbs, however they were shallow.A dimensional inspection was performed on the unopened samples and all of them were found outside the acceptance criteria.All samples were sent to the (b)(4) facility on 3/13/18.Samples were measured at (b)(4) and found below specification.The root cause for shallow barbs was identified as the method used in measuring the samples.A corrective /preventive action, capa (b)(4) was opened at the (b)(4) facility to address the issue.This complaint shall be included in the trend analysis.We will continue to closely monitor for experiences of this type.

• Brand Name: STRATAFIX
• Type of Device: STRATAFIX SXPD2B202 20S-8 #2 PDO 36 X 36
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; 24702-b, ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 7280431
• MDR Text Key: 100412029
• Report Number: 3010692967-2018-00002
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• PMA/PMN Number: K120827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/14/2017
• Device Model Number: SXPD2B202
• Device Catalogue Number: SXPD2B202
• Device Lot Number: AABR631
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention