MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2CT-1 #2 PDO 30 X 30

Model Number SXPD2B403

Device Problems Break (1069); Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problem Fluid Discharge (2686)

Event Date 10/20/2022

Event Type  Injury  

Manufacturer Narrative

A batch review of the finished good lot and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, sterilization, in-process, or final inspection process.Sterile samples from the same lot, photos of the incision site/failed device were not available for review.There were no retained samples available for review.If samples, or photos become available at a later date, the samples or information will be reviewed and added to the file and a follow-up report will be filed at that time.Adverse events including wound dehiscence and reactions are common risks/complications of any surgical procedure.There are many causes that can result in the wound opening, sutures failing or reaction, infection, abscess/leakage during or post-operative a procedure: the patient¿s health status, poor skin quality, thin skin; the risk is higher with a patient with a weak immune system, malnutrition, or chronic medical condition.The surgical procedure ¿ the risk increases with poor surgical techniques such as improper suturing, over-tightened sutures or inappropriate type of suture / size suture used for a particular procedure.Other factors - the risk is greater with smoking, obesity, premature post-surgery exercise, physical therapy activity and heavy lifting.The ¿precautions¿ section in the ifu for the device states, ¿the device contains a loop and barbs to anchor tissues and does not require knots to approximate opposing edges of a wound.For the device to function properly it must be anchored in the tissue by the deployment of the loop around robust tissue and then with the other segment subsequently engaged in the tissue by the barbs.Additionally, when completing placement of the barbed segment, an additional backstitch or bite of tissue lateral to the end of the incision is required to lock the stratafix¿ device in place.Care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments such as needle holders and forceps.To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point¿.Without receiving sterile devices from the same lot to tensile test, receiving photos of the surgical site/failed device or receiving detailed information regarding the pre-operative preparation of the devices, placement of the device in the tissue, method utilized to secure the device in the tissue as stated in the ifu, the patient¿s health status and specifics, quality of the tissue, surgeon¿s experience and/or technique, specifics regarding the post-operative events in physical therapy that may have occurred, a definitive root cause for the reported event cannot be confirmed with certainty.

Event Description

Our distributor reported that post op knee replacement surgery, the doctor performed two separate total knee replacements using stratafix within the closure.Everything was described as normal during the procedure.After the patient was in recovery and the physical therapist came to start getting the patients knee moving.The physical therapist heard a loud pop as the knee was bent and described seeing oozing from the wound.This incident was reported by the head of materials management within the hospital who said that the surgeon attributed the popping and oozing to the stratafix breaking.I have not been able to receive any information from the surgeon regarding the incident and will provide additional information once i have been able to speak with him.The patient did experience a post-op device malfunction.Additional information received.Our distributor¿s sales representative indicated that two sutures have been maintained from the two reported lots.One is opened with the needles cut off by the hospital, the other remains sterile.The patients were elderly 70 and 78, with a bmi of 28 and 32, no other pre-existing conditions were given.One patient was being helped out of bed and the popping was heard as the patients body weight shifted to the knee.The other patients slipped getting out of bed.The patient did not fall, but horizontal pressure was placed on the knee resulting in a popping sound.One patient reportedly footing slipped but did not completely fall.The events occurred the following day after surgery.Both patients were readmitted to the operating room to close the wound.The surgeon did not use the stratafix, but rather used interrupted vicryl with no issues.The first patient was able to go home the same day after the wound was closed by the surgeon.The second patient stayed at the hospital through the weekend, but no reason was given for the extended stay.Surgeon has over 30 years of experience, he has been using the same code of stratafix for several years on all of his total knees with no issues.Before using stratafix he used a continuous 1 pds, then several years ago started using 1 pdo spiral stratafix.Surgeon has had a case following the incident and continues to use the same code of stratafix with confidence.The two patients that the event occurred already had a follow up procedure to re close the wound.[doctor] also has performed another total knee since the incident with no further issues.

• Brand Name: STRATAFIX
• Type of Device: 2CT-1 #2 PDO 30 X 30
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.; corredor tijuana rosarito 2000; 24702 b, ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis jauregui giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 15708440
• MDR Text Key: 302829295
• Report Number: 3010692967-2022-00053
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031207950
• UDI-Public: (01)10705031207950(20)16(17)260831(10)B923LQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120827
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/21/2022,11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPD2B403
• Device Lot Number: B923LQE
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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; Other
• Patient Age: 70 YR