MCRYL+ VIO 36IN 3-0 S/A FS-2
Report
- Report Number
- 2210968-2025-03417
- Event Type
- Malfunction
- Date Received
- April 2, 2025
- Report Date
- July 2, 2025
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- UDI-DI
- 10705031218635
- PMA / PMN Number
- K050845
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT#: (B)(4). H6: COMPONENT CODE: G07002 - DEVICE EVALUATION PENDING. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: PRODUCT CODE: MCP922H; LOT#: PKK336 WAS RECEIVED FOR ANALYSIS, BUT NOT INITIALLY REPORTED. PLEASE CONFIRM IF LOT#: PKK336 ALSO BELONGS TO THIS COMPLAINT OR IF IT WAS SENT IN ERROR. YES, IT BELONGS TO THIS COMPLAINT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. CORRECTED DATA: D3 MANUFACTURER EMAIL.
PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 4/2/2025. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WERE ANY OF THE THREE CASES PREVIOUSLY REPORTED TO ETHICON? IF SO, WHAT ARE THE REFERENCE NUMBERS? A CAT HAD CONTINUOUS SUTURE COMPLETELY APPEAR SHREDDED IN VARIOUS AREAS OF THE ENTIRE SUTURE LINE. WHAT IS THE PROCEDURE DATE? WHAT ARE THE PRODUCT CODE AND LOT NUMBER? A DOG HAD INTERRUPTED SUTURES, AND 80% OF THESE SUTURES FRAYED AND WERE NO LONGER INTACT OR HOLDING. WHAT IS THE PROCEDURE DATE? WHAT ARE THE PRODUCT CODE AND LOT NUMBER? A DOG HAD INTERRUPTED SUTURES THAT APPEARED NOT TO HOLD AND FRAYED. ONLY 1 OR 2 WAS INTACT WITH SOME FRAYING. WHAT IS THE PROCEDURE DATE? WHAT ARE THE PRODUCT CODE AND LOT NUMBER? ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: IF POSSIBLE, PLEASE CONFIRM THE NUMBER OF SUTURES OBSERVED TO BE FRAYED POST-OPERATION. IT WAS MENTIONED THAT ALL MONOCRYL SUTURES WERE RETURNED. WERE ANY DEFICIENCIES OBSERVED IN THEM? IS THIS DEVICE OR SAMPLES FROM SAME LOT AVAILABLE FOR ANALYSIS? IF YES, TO WHOM SHOULD THE SHIPPER KIT BE SENT? (PLEASE PROVIDE CONTACT NAME, DEPARTMENT, STREET ADDRESS INCLUDING ZIP, NO PO BOX PLEASE, EMAIL ADDRESS, AND PHONE NUMBER) CREDIT WAS REQUESTED. PLEASE PROVIDE THE ETHICON PO NUMBER TO PROCESS THE REQUEST. WE HAD 3 ANIMALS EVISCERATE POST OPERATIVELY . ALL HAD THIS OCCUR WITHIN 5 DAYS AFTER THE PROCEDURES. 2 DOGS AND 1 CAT. 1 - HAD HER ( CAT ) CONTINUOUS SUTURE COMPLETELY APPEAR SHREDDED IN VARIOUS AREAS OF THE ENTIRE SUTURE LINE. 2- HAD INTERRUPTED SUTURES HAD 80% OF THESE SUTURES FRAYED AND NO LONGER INTACT OR HOLDING. 3- ALSO HAD INTERRUPTED SUTURES THAT APPEARED NOT TO HOLD AND FRAYED . ONLY 1 OR 2 WAS INTACT WITH SOME FRAYING. ALL ANIMALS WERE TAKEN BACK TO THE OPERATING ROOM AND THE INCISIONS ALL EXPLORED. ANY FRAGMENT OF FRAYED SUTURE WAS REMOVED AND THE INCISIONAL AREA CLEANED AND FRESHENED. THE INCISIONS WERE CLOSED WITH ALL PDS SUTURES AND STAPLES FOR THE DOGS. ANIMALS WERE ALL PLACED ON ADDITIONAL PAIN MEDICATIONS AND ANTIBIOTICS. ALL PATIENTS HAD BEEN ON RESTRICTED EXERCISE AND LEASH WALKED ONLY. THIS IS OUR STANDARD OF CARE FOR ALL SURGICAL PATIENTS. AS OF TODAY I STILL HAVE ALL THE SUTURES IN THE CLINIC. THEY HAVE NOT BEEN USED SINCE WE EXPERIENCED THESE INCIDENTS, THERE WERE NO UNUSUAL OR DEFICIENCIES SEEN UPON REMOVAL FROM THEIR PACKAGES. ALL THE MONOCRYL IS WAITING TO BE PICKED UP . I NEVER KNEW WHERE TO SEND THE BOXES . I BELIEVE I LISTED ALL THE MONOCRYL LOTS AND NUMBERS IN A PRIOR CORRESPONDENCE . I WILL RESEND ALL OF THEM TODAY. DUE TO THIS ISSUE WE DO NOT WISH TO USE MONOCRYL AT THIS TIME. THEREFORE, I AM RETURNING ALL THAT STOCK . 1. O MONOCRYL # Y 346H, LOT # SJMLAE, EXP: 07/31/2027 # 21, 2. 3-0 MONOCRYL # MCP923G LOT # UAMQTZ EXP: 12/31/2025 # 12, 3. 2-0 MONOCRYL # Y943G LOT # UAMASH EXP:12/31/28 # 7, 4. 3-0 MONOCRYL # MCP923 LOT # UBMHHK EXP : 01/31/26 # 4, 5. 2-0 MONOCRYL # Y9543G LOT# UAMAMD EXP: 12/31/28 # 12. I HAVE CONTACTED (FACILITY) FOR THE PO RECEIPTS YOU HAVE REQUESTED. HOPEFULLY, I WILL BE ABLE TO SEND THOSE IN THE NEXT FEW DAYS. -WAS ANY QUALITY DEFICIENCY/NON-CONFORMANCE NOTED WITH THE SUTURE BEFORE USE, DURING USE, DURING POST-OP EXAMINATION OR DURING RE-OPERATION IF PERFORMED? IN RESPONSE TO YOUR EMAIL I AM NOT EXACTLY SURE OF WHAT YOU WANT. SO I AM GOING TO ANSWER THE LISTED QUESTIONS. AS FAR AS DEFICIENCY /NON-CONFORMANCE BEFORE ,DURING OR AFTER USE OF THE ABOVE SUTURE . NO, WE DID NOT NOTICE ANY ISSUES WITH SAID PRODUCT. HOWEVER, WHEN WE HAD TO DEBRIDE THE EVISCERATED INCISION THERE WAS FRAYING ON SOME OF THE SUTURES, ALTHOUGH NOT CONSISTENTLY. COULD YOU KINDLY PERFORM THE FOLLOW-UP ATTEMPT FOR THE PRODUCT RETURN? PLEASE ENSURE THAT THE SHIPMENT TRACKING NUMBER IS PROVIDED: THESE PRODUCTS WERE ALL PURCHASED THROUGH PATTERSON VETERINARY SUPPLY. WE CHOOSE TO RETURN ALL MONOCRYL THAT WE HAVE IN STOCK . 2-0 MONOCRYL # Y943G #20, 3-0 MONOCRYL #MCP923G #16, 4-0 MONOCRYL #MCP922H # 16, 0 MONOCRYL #Y346H # 21. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.
PRODUCT COMPLAINT # (B)(4) H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION: H6, D9, H3 H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE OPEN BOX WITH TWELVE REPRESENTATIVE UNOPENED SAMPLES WAS RECEIVED FOR ANALYSIS. PRODUCT CODE MCP923G. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR EVALUATION. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND, AND NO ISSUES RELATED TO FRAYING SUTURES OR ANOMALIES WERE OBSERVED DURING THE EVALUATION. ALSO, A TACTILE TEST WAS PERFORMED WITH THE AFFECTED PARTS OF THE THUMB AND FOREFINGER AND NO ANOMALIES WERE DETECTED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.
IT WAS REPORTED THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE INTERRUPTED SUTURES HAD 80% OF THESE SUTURES FRAYED AND NO LONGER INTACT OR HOLDING. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2372395 | MCRYL+ VIO 36IN 3-0 S/A FS-2 | SUTURE, ABSORBABLE, SYNTHETIC | GAM | ETHICON INC. | UAMQTZ | 10705031218635 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |