PDS PLUS VIO 20X45CM 0 S/A CTB-1 CR
Report
- Report Number
- 2210968-2024-10480
- Event Type
- Malfunction
- Date Received
- October 2, 2024
- Report Date
- December 10, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- NEW
- PMA / PMN Number
- K061037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(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, H3, H6. INVESTIGATION SUMMARY: THE PRODUCT RECEIVED FOR ANALYSIS WAS IDENTIFIED AS PRODUCT CODE PDPB740Z AND WERE ASSOCIATED WITH RO-1040046 - RO-1040047 VISUAL INSPECTION AND METALLURGICAL ANALYSIS WERE PERFORMED ON THE RETURNED PRODUCT. A FRACTURE WAS OBSERVED IN THE BODY OF SAMPLE A. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. THE NEEDLE WAS NOTED WITH MARKS THAT APPEARS TO BE BY SURGICAL INSTRUMENT. A SCANNING ELECTRON MICROSCOPE (SEM) WAS USED TO EXAMINE THE FRACTURED SURFACES AND SURROUNDING AREA OF THE NEEDLES. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE EVALUATION OF THE SAMPLE REVEALED THE FRACTURES WERE COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE OVERLOAD FAILURE. THESE WERE DUCTILE FRACTURES. A FRACTURE WAS OBSERVED IN THE BODY OF SAMPLE B. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. THE NEEDLE WAS NOTED WITH MARKS THAT APPEARS TO BE BY SURGICAL INSTRUMENT. 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 THE SAMPLE REVEALED THE FRACTURES WERE COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE OVERLOAD FAILURE. THESE WERE DUCTILE FRACTURES. THE EVIDENCE OF THIS EXAMINATION INDICATES THAT THE BREAKAGE OCCURRED FROM MECHANICAL DEFORMATION, INDENTS AND SCRATCHES, DUE TO GRIPPING, BENDING AND OVERSTRESSING OF THE NEEDLE. THERE IS NO EVIDENCE OF ANY MATERIAL FLAW THAT WOULD CAUSE PREMATURE FAILURE. THE NEEDLE BREAKAGE WAS CONFIRMED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. CORRECTED INFORMATION: D4, H4. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE REPORTED POSSIBLE BATCH NUMBERS: UBMCZS EXPIRATION DATE: JAN/31/2026 DATE OF MFG.: FEB/7/2024. UBMCXA EXPIRATION DATE: JAN/31/2026 DATE OF MFG.: FEB/7/2024. A REVIEW OF THE MANUFACTURING RECORD EVALUATION FOR ALL POSSIBLE BATCH NUMBERS WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. D4: GTIN IS UNAVAILABLE THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE FOLLOWING INFORMATION WAS RECEIVED: IT WAS REPORTED THAT UBMCXA OR UBMCZS WERE THE LOT NUMBERS CORRESPONDING TO THE INVOLVED DEVICES. - PLEASE CONFIRM THE LOT NUMBER OF EACH DEVICE INVOLVED (2) IN THE REPORTED EVENT. NO. THE TOTAL NUMBER OF IMPACTED PRODUCT IS 1, BUT THE LOT NUMBER IS EITHER UBMCXA OR UBMCZS. IT WAS REPORTED THAT ""...THE BODY PART OF NEEDLE WAS BROKEN. IT HAS BEEN REMOVED AFTER CONFIRMING BY X-RAY...."" WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? YES WHAT MEASURES WERE TAKEN TO RETRIEVE THE BROKEN PIECE(S)? AFTER IDENTIFIED THE NEEDLE, THE PIECE WAS RETRIEVED NORMAL INSTRUMENT WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE(S)? NO *IF NOT RETRIEVED, IN WHAT TISSUE STRUCTURE THE NEEDLE PIECE(S) WERE RETAINED? IS? RETRIEVED IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE(S) IN THE FUTURE? PLEASE PROVIDE DETAILS.? N/A PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. THE DEVICE HAS BEEN RECEIVED AT SUKAGAWA AND WILL BE SHIPPED. PLEASE CHECK RMAO.
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 10/2/2024. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. D4: UDI: (01)GTIN IS UNAVAILABLE THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 THERE ANY PATIENT CONSEQUENCES? IF YES, PLEASE DESCRIBE. IT WAS REPORTED THAT UBMCXA OR UBMCZS WERE THE LOT NUMBERS CORRESPONDING TO THE INVOLVED DEVICES. PLEASE CONFIRM THE LOT NUMBER OF EACH DEVICE INVOLVED (2) IN THE REPORTED EVENT. IT WAS REPORTED THAT "...THE BODY PART OF NEEDLE WAS BROKEN. IT HAS BEEN REMOVED AFTER CONFIRMING BY X-RAY...." WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? WHAT MEASURES WERE TAKEN TO RETRIEVE THE BROKEN PIECE(S)? WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE(S)? IF NOT RETRIEVED, IN WHAT TISSUE STRUCTURE THE NEEDLE PIECE(S) WERE RETAINED? IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE(S) IN THE FUTURE? PLEASE PROVIDE. DETAILS. PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ). PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. 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.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, AT THE BODY PART OF NEEDLE WAS BROKEN. IT HAS BEEN REMOVED AFTER CONFIRMING BY X-RAY. IT WAS A CONTROL RELEASE NEEDLE. IT WAS USED ON FASCIA. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35634 | PDS PLUS VIO 20X45CM 0 S/A CTB-1 CR | SUTURE, SURGICAL, ABSORBABLE | NEW | ETHICON INC. | UBMCZS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |