DRAW TIGHT SUTURE ANCHORS
Report
- Report Number
- 3007319107-2023-00006
- Event Type
- Malfunction
- Date Received
- February 13, 2023
- Date of Event
- January 23, 2023
- Report Date
- March 17, 2023
- Manufacturer
- PARCUS MEDICAL LLC
- Product Code
- MBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS CASE IS STILL UNDER INVESTIGATION. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT. SUPPLEMENTAL INFORMATION. THE REPORTED EVENT IS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURING PLANT FOR ANALYSIS. IT WAS REPORTED TO PARCUS BY THE DISTRIBUTOR THAT AN ANCHOR PULLED OUT OF THE BONE DURING A LAR PROCEDURE FOR A 36 YEAR OLD MALE PATIENT. THE ANCHOR WAS NOT IMPLANTED, IT WAS DISCARDED, A LARGER ANCHOR WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS THOUGHT THAT THE ANCHORS PULLED OUT DUE TO POOR BONE QUALITY AND PROPER SURGICAL TECHNIQUE WAS USED. THE PATIENT HAD MODERATE BONE DENSITY THAT DID NOT APPEAR TO BE TOO HARD OR SOFT. THE PRODUCT WAS NOT USED PRIOR TO THIS PROCEDURE AND THERE WAS A 20 MINUTE DELAY SINCE THE FIRST DRAWTIGHT PULLED OUT IMMEDIATELY AND A SECOND DRAWTIGHT PULLED OUT AFTER ALREADY HAVING BEEN SEWN THROUGH THE RETINACULUM AND HE WAS MAKING HIS FINAL KNOTS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THERE WAS NO REPORT OF ANY UNUSUAL APPEARANCE WITH THE PACKAGING AT THE TIME OF USE. A BATCH RECORD REVIEW WAS PERFORMED . THERE WERE NO NON-CONFORMANCES DOCUMENTED HOWEVER THERE IS A DEVIATION FOR THIS PRODUCT. THE DEVIATION DOES NOT IMPACT THE MATERIAL INTEGRITY OR PERFORMANCE OF THE PRODUCT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION. THIS CASE WILL BE MONITORED AND TRENDED FOR FUTURE ANALYSIS.
ON 23JAN2023 IT WAS REPORTED TO PARCUS LLC THAT THE DRAW TIGHT ANCHOR PULLED OUT OF A 36 YEAR OLD MALE PATIENT'S BONE DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD POOR BONE QUALITY. THE COMPLAINANT DID NOT BELIEVE THAT THERE WAS ANY PROBLEM WITH THE ANCHOR. THE ANCHOR WAS DISCARDED. THIS IS ONE OF THREE EVENTS INVOLVING THE SAME PATIENT AND PROCEDURE. A LARGER SIZE ANCHOR WAS USED AS A REPLACEMENT. IT WAS NOT DISCLOSED THE BRAND OR MANUFACTURER OF THE REPLACEMENT ANCHOR. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. THERE WAS NO DELAY OF THE PROCEDURE REPORTED. ADDITIONAL INFORMATION WAS SOLICITED.
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 23JAN2023, IT WAS REPORTED TO PARCUS LLC THAT THE DRAW TIGHT ANCHOR PULLED OUT OF A 36 YEAR OLD MALE PATIENT'S BONE DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD POOR BONE QUALITY. THE COMPLAINANT DID NOT BELEIVE THAT THERE WAS ANY PROBLEM WITH THE ANCHOR. THE ANCHOR WAS DISCARDED. THIS IS ONE OF THREE EVENTS INVOLVING THE SAME PATIEN AND PROCEDURE. A LARGER SIZE ANCHOR WAS USED AS A REPLACEMENT. IT WAS NOT DISCLOSED THE BRAND OR MANUFACTURER OF THE REPLACEMENT ANCHOR. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. THERE WAS NO DELAY OF THE PROCEDURE REPORTED. ADDITIONAL INFORMATION WAS SOLICITED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1672737 | DRAW TIGHT SUTURE ANCHORS | FASTNER, FIXATION, NONDEGRADABLE, SOFT TISSUE | MBI | PARCUS MEDICAL LLC | 17561 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Male |