MONOCRYL PLUS UD 27IN USP4-0
Report
- Report Number
- 2210968-2025-11024
- Event Type
- Malfunction
- Date Received
- September 25, 2025
- Date of Event
- August 28, 2025
- Report Date
- January 7, 2026
- Manufacturer
- ETHICON INC.
- Product Code
- GAM
- PMA / PMN Number
- K050845
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # (B)(4). 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 RECEIVED FOR ANALYSIS WAS MCP4394H. VISUAL INSPECTION AND METALLURGICAL ANALYSIS WERE PERFORMED ON THE RETURNED PRODUCT. A FAILED SUTURE NEEDLE, LABELED AS (B)(4), WAS SUBMITTED TO HERRERA, STAFFORD AND ASSOCIATES, LLC (HSA) FOR FRACTOGRAPHIC EVALUATION ON NOVEMBER 3, 2025. THE COMPONENTS WERE IDENTIFIED AS PRODUCT CODE MCP4394H. IT WAS REQUESTED THAT HSA ASSESS THE FRACTURE MODE OF THE FAILURE. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACE AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACE WAS EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE EVALUATION OF (B)(4) REVEALED THE FRACTURE WAS COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE OVERLOAD FAILURE. MECHANICAL OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDES ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THESE WAS DUCTILE FRACTURES.
PRODUCT COMPLAINT # (B)(4). 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. ADDITIONAL INFORMATION: D9, G4, H3, H6. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE UNOPENED FOIL PACKET THAT PERTAINS TO PRODUCT CODE MCP4394H WAS RECEIVED FOR ANALYSIS. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLE, THE PACKET WAS OPENED. THE SWAGE AND ATTACHMENT AREA WERE NOTED AS EXPECTED. THE TIP AND BODY OF THE NEEDLE WERE EXAMINED UNDER MAGNIFICATION AND NO ANOMALIES OR ISSUES RELATED TO NEEDLE BREAKAGE WERE FOUND. IN ADDITION, THE SAMPLE WAS TESTED BY RESISTANCE TEST TO NEEDLE AND MET THE REQUIREMENTS. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT. TO AVOID THIS KIND OF DAMAGE: GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE ATTACHMENT END TO THE POINT. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.
PRODUCT COMPLAINT # (B)(4) D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01)GTIN IS NOT AVAILABLE. H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: LOSS OF MICRO NEEDLE FRAGMENT IN THE PATIENT'S TISSUES THAT I MUST TAKE CARE TO REMOVE AND DO NOT FORGET. USE OF MINIMUM 3 THREADS TO MAKE AN OVERJET ON THE CHEST, THEREFORE EXCESSIVE CONSUMPTION AND PROLONGED INTERVENTION TIME. LOSS OF MICRO FRAGMENT OF NEEDLE IN THE TISSUES OF THE PATIENT THAT I MUST TAKE CARE TO REMOVE AND DO NOT FORGET, YOU WILL FIND ATTACHED PHOTOS TESTIFYING TO THIS INCIDENT, WITH A NEEDLE BROKEN IN THE DERMIS OF THE PATIENT DURING AN OVERJET. ANOTHER TIME THE FRAGMENT JUMPED ON THE FIELD AND WE MUST FIND IT.... THERE IS NO TISSUE DAMAGE. THE NEEDLES SENT ARE THOSE OF A SINGLE INTERVENTION. THE REASON OF USING MORE THREADS DURING SURGERY BECAUSE NEEDLE BROKE. IT WAS REPORTED THE USE OF MINIMUM 3 THREADS TO MAKE AN OVERJET ON THE CHEST, COULD YOU PLEASE PROVIDE MORE DETAILS ABOUT THE REASON OF USING MORE THREADS DURING SURGERY? - USE OF MINIMUM 3 THREADS TO OVERSPRAY THE CHEST, THEREFORE EXCESSIVE CONSUMPTION AND PROLONGED INTERVENTION TIME COULD YOU TELL ME IF THERE WAS A PRESCRIPTION FOR STEROIDS OR ANTIBIOTICS FOR THE PATIENT'S WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? NO X-RAYS WERE NEEDED; THEY WERE ALWAYS FOUND SEARCHING WELL. IN WHICH TISSUE STRUCTURE WAS THE BROKEN NEEDLE LOCATED? DERMIS WHAT IS THE SURGEON'S OPINION OF THE POTENTIAL CONSEQUENCES FOR THE PATIENT? WHAT IS THE CURRENT STATUS OF THE PATIENT? FOR THE MOMENT THERE HAVE BEEN NO IMMEDIATE SERIOUS COMPLICATIONS RELATED TO THESE INCIDENTS, BUT SINCE THEY ARE DAILY, IT IS LIKELY TO HAPPEN (FOREIGN BODY FOR LIFE, RECOVERY IN THE OPERATING ROOM FOR EXCISION, LOCAL SUPERINFECTION, DEATH...) 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. HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY? WHAT IS THE TOTAL NUMBER OF PROCEDURES? RECOVERY? IF YES, PLEASE PROVIDE MEDICATION NAME, ROUTE AND DOSE. DID THE NEEDLE FALL INTO THE PATIENT? WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? WHAT MEASURES WERE IMPLEMENTED TO RETRIEVE THE BROKEN PIECE? WAS THERE ANY ADDITIONAL TISSUE DAMAGE RESULTING FROM THE SEARCH FOR THE NEEDLE PIECE? DOES A FRAGMENT OF THE NEEDLE REMAIN IN THE PATIENT¿S TISSUE? IF SO, IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE IN THE FUTURE? IF SO, COULD YOU PLEASE PROVIDE THE SCHEDULED DATE FOR THE REMOVAL? 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.
PRODUCT COMPLAINT # (B)(4). 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 RECEIVED FOR ANALYSIS WAS MCP4394H VISUAL INSPECTION AND METALLURGICAL ANALYSIS WERE PERFORMED ON THE RETURNED PRODUCT. FIVE FAILED SUTURE NEEDLES, LABELED AS (B)(4) WERE SUBMITTED TO HERRERA, STAFFORD AND ASSOCIATES, LLC (HSA) FOR FRACTOGRAPHIC EVALUATION ON NOVEMBER 3, 2025. THE COMPONENTS WERE IDENTIFIED AS PRODUCT CODE MCP4394H. IT WAS REQUESTED THAT HSA ASSESS THE FRACTURE MODE OF THE FAILURES. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLES. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE EVALUATION OF (B)(4) REVEALED THE FRACTURES WERE COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE OVERLOAD FAILURE. MECHANICAL OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDES ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THESE WERE DUCTILE FRACTURES.
PRODUCT COMPLAINT # (B)(4). 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. ADDITIONAL INFORMATION: H6. UPDATED INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE UNOPENED FOIL PACKET THAT PERTAINS TO PRODUCT CODE MCP4394H WAS RECEIVED FOR ANALYSIS. IN ORDER TO EVALUATE THE CONDITION OF THE RETURNED SAMPLE, THE PACKET WAS OPENED. THE SWAGE AND ATTACHMENT AREA WERE NOTED AS EXPECTED. THE TIP AND BODY OF THE NEEDLE WERE EXAMINED UNDER MAGNIFICATION AND NO ANOMALIES OR ISSUES RELATED TO NEEDLE BREAKAGE WERE FOUND. IN ADDITION, THE SAMPLE WAS TESTED BY RESISTANCE TEST TO NEEDLE AND MET THE REQUIREMENTS. THREE PHOTOS WERE PROVIDED THE FOLLOWING: TWO SHOW A SUTURE NEEDLE PASSING THROUGH TISSUE; THE THIRD SHOWS A BROKEN NEEDLE. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT. TO AVOID THIS KIND OF DAMAGE: GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE ATTACHMENT END TO THE POINT. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE BROKEN DURING PLACEMENT OF ANOTHER SUTURE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333574 | MONOCRYL PLUS UD 27IN USP4-0 | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | GAM | ETHICON INC. | 10951A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |