MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION MEXICO STRATAFIX; STRAFIX SUTURE PDO

Model Number SXPD2B405

Device Problem Device Slipped (1584)

Patient Problem Failure to Anastomose (1028)

Event Date 09/09/2018

Event Type  Injury  

Manufacturer Narrative

The sample devices from lot aacm233 were returned referencing the above complaint.Once the specific lot was identified a thorough review of the device history records was performed and a visual review, and testing was performed on the sterile samples.Additional information was requested; however, very little details were provided explaining the procedure, post-operative compliance or if any intervention was required.A review of the device history records for the reported finished good lot and raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.There were no other complaints received for this specific finished good lot.Samples from the reported lot were received, visually reviewed, measured for barb placement and depth by our quality team.No visual defects were observed and the barbs meet all current requirements according the current product design for item sxpd2b405.Without receiving pertinent details regarding the pre-operative preparation of the device, surgeon's technique, patient¿s pre-existing health conditions/allergies, post-operative instructions or events that may have occurred and/or contributed to the reported event, a definitive root cause cannot be determined at this time.Capa [(b)(4)] was initiated to review the barbing process and address the reported failure of [not barbed/ shallow barbs; barbs not prominent on the device].Based on the investigation and information collected and analyzed, there are multiple related conditions that could contribute to the reported failure.The following are possible root causes that have been identified throughout the barbing process.Re-training on procedure (b)(4).During the investigation, it was determined that the operators require a greater knowledge of the procedure and setup of the machines.There is a variation in the diameter of the suture between supplier lots.Some areas on the length of the suture can measure closer to the minimum requirement.When this thinner suture is being processed and the machine is set to cut the barbs, the barbs are not cut as deep as the barbs on a thicker, more robust piece of suture material.This can potentially occur within the same lot or box of product and results in variances in how the barbs appear from piece to piece.The suture is often loose on the spool and this requires the machine to be adjusted.The blade loses its edge after several cuts during the process.Worn blades on the barbing machine have an effect on how the barbs are cut on the suture material.The operator can install the wrong ¿anvil¿ during the initial machine setup.The position and setup of the blade will cause a variation of the suture cut.As part of the process review and the investigation the following improvements "has" been implemented or will be implemented to the barbing process and are continuously reviewed and improved: a ¿continuous improvement¿ certification program was created for all barbing machine operators so they are well trained on the process and the barbing operation [completed on 08/30/2018].A form (b)(4) was updated by quality to ensure the correct setup on the barbing machine [completed on 09/13/2018].A pokayoke was installed on all the blade bases of the barbing machine, to avoid variation during the blade set up installation changes [completed on 08/31/2018].The procedure (b)(4), revision 4 from (b)(4) facility was updated to include all the data from the (b)(4), revision 16 from (b)(4) [completed on 06/29/2018].The expiration date of the ig charts (reference document for angle and depth measurement of barbs) was changed to every six (6) months [completed on 10/02/2018].The ig chart (reference document for angle and depth measurement of barbs) will be revised to be ¿user friendly¿ for the operator/inspectors [completed on 10/26/18].A new visual aid (b)(4) was created to measure depth and angle of the barbs.All operators involved in the process have been trained by our engineers [completed on 10/02/2018].The engineering team updated the procedure (b)(4) to set the frequency to change the blades at least once per week [completed on 10/02/2018].An engineering study was made to calculate the life of the blade edge [ completed on 10/31/2018].

Event Description

It was reported 9 days after knee tep surgery the barbs of the suture did not grip and the fascia layer of the tissue was open.No additional details were disclosed about the procedure, compliance to post-op instructions or the type of intervention that was provided.

• Brand Name: STRATAFIX
• Type of Device: STRAFIX SUTURE PDO
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION MEXICO; corredor tijuana rosarito 2000; #24702 b, ejido francisco vill; tijuana 22235 ; MX 22235
• Manufacturer Contact: ronald giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 8278926
• MDR Text Key: 134142204
• Report Number: 3010692967-2019-00002
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: SXPD2B405
• Device Lot Number: AACM233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 09/09/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2018
• Date Manufacturer Received: 09/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other