MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION LOOK; LOOK - ABSORBABLE GUT SUTURES

Model Number 553B

Device Problem Product Quality Problem (1506)

Patient Problem Wound Dehiscence (1154)

Event Date 12/15/2022

Event Type  Injury  

Event Description

The distributor reported for the end user, the sutures used are not lasting very long therefore patient(s) wounds are opening as a result.The customer completed a questionnaire to obtain additional details of the event.A 69-year-old male patient returned on (b)(6) 2022, for re-suture of an opened incision.The patient ''s incision was re-sutured and was reported in stable condition.The doctor noted, the patient followed all post-operative instructions.No events occurred that could have affected the absorption rate or effectiveness of the suture.No defects or abnormalities were observed on the packages or to the devices prior to use.

Manufacturer Narrative

A batch review of the reported lot indicated there were no quality issues noted throughout the incoming inspection, manufacturing, in-process, or final inspection processes.Sterile samples from the reported lot were not returned for testing/review.No photos of the incision site/failed sutures were provided for review.If samples, photos or additional details become available, a follow-up report will be submitted with the test results and/or a summary of the review.Plain gut suture is naturally absorbable surgical gut suture.Gut absorbs by simple enzymatic mechanism and absorption is not as predictable as in synthetic sutures.Plain gut tends to absorb faster in infected tissues.The initial tensile strength is lost within 7 to 10 days and is absorbed completely in approximately 60 to 70 days.The precautions section of the ifu for this material states, ¿infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances wound dehiscence are typical or foreseeable risks associated with any suture and hence are also potential complications associated with gut suture¿.The adverse reactions section of the ifu states, ¿adverse effects associated with the use of this device may include wound dehiscence; variable rates of absorption over time (depending on the type of suture used, the presence of infection and tissue site); failure to provide adequate wound support in closure of sites where expansion, stretching or distention occur, etc.Failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, allergic response in patients with known sensitivities to collagen or chromium which may result in an immunological reaction resulting in inflammation, tissue granulation or fibrosis, wound suppuration and bleeding as well as sinus formation, infection, moderate tissue inflammatory response characteristic of foreign body response and local irritation of the wound site¿.Without receiving photos of the dehisced incision, or receiving details regarding the exact surgery dates, type of procedure performed, the number of days the suture remained within the patient and when the reactions/dehiscence occurred, placement of the suture within the tissue, patients health history/health of tissue where suture was placed, or the surgeon¿s technique, a definitive root cause cannot be confirmed at this time.No corrective actions are warranted at this time.

Manufacturer Narrative

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.No additional complaints have been reported for this lot.Sterile samples from the reported lot were received (rma # 43515) for visual review and testing.No defects or abnormalities were observed on the devices or the packages.All devices and packages were wet with alcohol solution.The devices met current specifications including the usp tensile requirements for a 3-0 plain gut device.The suture size used to manufacture the reported lot was 3-0.Usp size 7-0 is the only size gut suture that is packaged dry.Usp size 6-0 through 4 gut sutures are packaged in a wetting solution and should be utilized promptly upon removing from the foil package.If these devices are opened, removed from the foil package, and left exposed, the alcohol solution will evaporate, allowing the sutures to become dry, brittle and possibly break during use.Natural absorbable sutures, like the products in this report, have a tendency to fray during knot construction.Additionally, there is considerably more variability in the retention of tensile strength than is found with other types of sutures.Plain gut suture is naturally absorbable surgical gut suture.Gut absorbs by simple enzymatic mechanism and absorption is not as predictable as in synthetic sutures.Plain gut tends to absorb faster in infected tissues.The initial tensile strength is lost within 7 to 10 days and is absorbed completely in approximately 60 to 70 days.The precautions section of the ifu for this material states, ¿infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances wound dehiscence are typical or foreseeable risks associated with any suture and hence are also potential complications associated with gut suture¿.The adverse reactions section of the ifu states, ¿adverse effects associated with the use of this device may include wound dehiscence; variable rates of absorption over time (depending on the type of suture used, the presence of infection and tissue site); failure to provide adequate wound support in closure of sites where expansion, stretching or distention occur, etc.Failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, allergic response in patients with known sensitivities to collagen or chromium which may result in an immunological reaction resulting in inflammation, tissue granulation or fibrosis, wound suppuration and bleeding as well as sinus formation, infection, moderate tissue inflammatory response characteristic of foreign body response and local irritation of the wound site¿.Without receiving photos of the dehisced incision, or receiving details regarding the shipping, storage and handling of the material, exposure time prior to use, exact surgery dates, type of surgery performed, the number of days the suture remained within the patient and when the reactions/dehiscence occurred, placement of the suture within the tissue, patient¿s health history/health of tissue where suture was placed, or the surgeon¿s technique, a definitive root cause cannot be confirmed at this time.

• Brand Name: LOOK
• Type of Device: LOOK - ABSORBABLE GUT SUTURES
• 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; 1100 berkshire blvd.; ste 308; reading PA 19608
• Manufacturer Contact: kelly knappenberger ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 16138308
• MDR Text Key: 307101037
• Report Number: 3010692967-2023-00003
• Device Sequence Number: 1
• Product Code: GAL
• UDI-Device Identifier: 10848782009159
• UDI-Public: (01)10848782009159(17)270701(10)C727TWD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K896554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2022,03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 553B
• Device Lot Number: C727TWD
• Was the Report Sent to FDA?: No
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 12/22/2022
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• 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): Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male