TWIST KNOTLESS DEX
Report
- Report Number
- 3007319107-2024-00002
- Event Type
- Injury
- Date Received
- January 29, 2024
- Date of Event
- January 1, 2024
- Report Date
- March 5, 2024
- Manufacturer
- PARCUS MEDICAL LLC
- Product Code
- MBI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS CASE IS STILL UNDER INVESTIGATION AT THE MANUFACTURING PLANT. THE BRAND NAME, COMMON DEVICE NAME AND PRODUCT CODES ARE ASSUMED AND MAY BE REVISED UPON RECEIPT OF NEW AND RELEVANT INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT.
THIS CASE IS STILL UNDER INVESTIGATION AT THE MANUFACTURING PLANT. THE BRAND NAME, COMMON DEVICE NAME AND PRODUCT CODES ARE ASSUMED AND MAY BE REVISED UPON RECEIPT OF NEW AND RELEVANT INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT. THE REPORTED EVENT IS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURING PLANT FOR ANALYSIS. IT WAS REPORTED TO ANIKA BY THE DISTRIBUTOR THAT A SURGEON HAD TO DRILL OUT AN OLD ANCHOR TO PUT IN A NEW ANCHOR FOR A REVISION CASE AS THE 47-YEAR-OLD FEMALE PATIENT WHO HAD BEEN NON-COMPLIANT HAD NOT FOLLOWED AFTER CARE INSTRUCTIONS THAT RESULTED IN TEARING IN THE SURGERY SITE. THE PATIENT WALKED AND TORE THE TISSUE AROUND THE SURGERY. BASED ON THE INFORMATION PROVIDED, THERE WERE NO REPORTED ISSUES OR ABNORMALITIES WITH THE PACKAGING OR DEVICE DURING ITS USE. THERE WAS NO PATIENT DEATH. THERE WAS NO REPORT OF AN UNPLANNED OR UNSCHEDULED MEDICAL INTERVENTION. THERE WAS NO DELAY IN THE PROCEDURE. THE STATUS OF THE PATIENT IS UNKNOWN. A REVIEW OF THE BATCH RECORD WAS PERFORMED. THERE WAS NO NON-CONFORMANCES DOCUMENTED IN THE BATCH RECORD. A THREE-YEAR RETROSPECTIVE REVIEW OF ALL NON-CONFORMANCES WAS PERFORMED. THERE WAS NO NON-CONFORMANCES DOCUMENTED THAT WAS ASSOCIATED WITH THE REPORTED EVENT. THE PLAUSIBLE CAUSE OF THE REPORTED EVENT IS TRACED TO THE PATIENT BEING NONCOMPLIANT AND FAILED TO FOLLOW AFTER CARE INSTRUCTIONS RESULTING IN THE TISSUE NOT HEALING CORRECTLY RESULTING IN A REVISION PROCEDURE BEING PERFORMED. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED AND TRENDED FOR FUTURE ANALYSIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION.
THIS CASE IS STILL UNDER INVESTIGATION AT THE MANUFACTURING PLANT. THE BRAND NAME, COMMON DEVICE NAME AND PRODUCT CODES ARE ASSUMED AND MAY BE REVISED UPON RECEIPT OF NEW AND RELEVANT INFORMATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT.
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY PARCUS MEDICAL LLC OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, PARCUS MEDICAL LLC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 05JAN2023, THE DISTRIBUTOR REPORTED TO PARCUS MEDICAL LLC THAT A REVISION PROCEDURE WAS PERFORMED FOR A WOUND DEHISCENCE ON A 47-YEAR-OLD FEMALE PATIENT WHO WAS NONCOMPLIANT AFTER RECEIVING AN UNKNOWN PARCUS ANCHOR. THE ORIGINAL DATE THE PATIENT RECEIVED THE PARCUS ANCHOR IS UNKNOWN. THERE WAS NO DIRECT ALLEGATION THAT THE PARCUS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S NONCOMPLIANCE OR THE WOUND DEHISCENCE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION PRIOR TO OR DURING THE USE OF THE PARCUS ANCHOR. ADDITIONAL INFORMATION WAS SOLICITED. SUPPLEMENTAL REPORT. ADDITIONAL INFORMATION WAS PROVIDED, LOT NUMBERS AND PART NUMBER. THE PATIENT WAS LISTED AS NONCOMPLIANT. THERE WAS NO MALFUNCTION WITH THE DEVICE. THIS IS ONE OF THREE SUBMISSIONS FOR THE SAME EVENT.
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY PARCUS MEDICAL LLC OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, PARCUS MEDICAL LLC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 05JAN2023 THE DISTRIBUTOR REPORTED TO PARCUS MEDICAL LLC THAT A REVISION PROCEDURE WAS PERFORMED FOR A WOUND DEHISCENCE ON A 47-YEAR-OLD FEMALE PATIENT WHO WAS NONCOMPLIANT AFTER RECEIVING AN UNKNOWN PARCUS ANCHOR. THE ORIGINAL DATE THE PATIENT RECEIVED THE PARCUS ANCHOR IS UNKNOWN. THERE WAS NO DIRECT ALLEGATION THAT THE PARCUS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S NONCOMPLIANCE OR THE WOUND DEHISCENCE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION PRIOR TO OR DURING THE USE OF THE PARCUS ANCHOR. ADDITIONAL INFORMATION WAS SOLICITED. SUPPLEMENTAL REPORT. ADDITIONAL INFORMATION WAS PROVIDED, LOT NUMBERS AND PART NUMBER. THE PATIENT WAS LISTED AS NONCOMPLIANT. THERE WAS NO MALFUNCTION WITH THE DEVICE. THIS IS ONE OF THREE SUBMISSIONS FOR THE SAME EVENT.
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY PARCUS MEDICAL LLC OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, PARCUS MEDICAL LLC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 05JAN2023 THE DISTRIBUTOR REPORTED TO PARCUS MEDICAL LLC THAT A REVISION PROCEDURE WAS PERFORMED FOR A WOUND DEHISCENCE ON A 47-YEAR-OLD FEMALE PATIENT WHO WAS NONCOMPLIANT AFTER RECEIVING AN UNKNOWN PARCUS ANCHOR. THE ORIGINAL DATE THE PATIENT RECEIVED THE PARCUS ANCHOR IS UNKNOWN. THERE WAS NO DIRECT ALLEGATION THAT THE PARCUS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S NONCOMPLIANCE OR THE WOUND DEHISCENCE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION PRIOR TO OR DURING THE USE OF THE PARCUS ANCHOR. ADDITIONAL INFORMATION WAS SOLICITED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1649432 | TWIST KNOTLESS DEX | SCREW, FIXATION, BONE; FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE | MBI | PARCUS MEDICAL LLC | 18198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Required Intervention |