FDA Adverse Event
Malfunction
Summary report: N
JAWS NITINOL STAPLE SYSTEM
MDR report key: 11902243
·
Received May 28, 2021
Report
- Report Number
- 3008650117-2021-00095
- Event Type
- Malfunction
- Date Received
- May 28, 2021
- Date of Event
- April 28, 2021
- Report Date
- May 28, 2021
- Manufacturer
- PARAGON 28, INC.
- Product Code
- JDR
- PMA / PMN Number
- K170923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
PLEASE DISREGARD THE COMMENT "NO ADVERSE EVENT" . "DEVICES ARE EXPECTED TO BE RETURNED" HOWEVER, THIS DEVICE WAS DISCARDED.
Description of Event or Problem · 0
THE COMPLAINT "INITIATOR" REPORTED A DRILL BARREL WAS REPORTED TO BE BLOCKED.
Additional Manufacturer Narrative · 1
IDENTIFYING INFORMATION, SUCH AS THE LOT NUMBER OF THE DEVICE WAS NOT REPORTED TO PARAGON 28. DEVICES ARE NOT EXPECTED TO BE RETURNED FOR THE MANUFACTURER REVIEW/INVESTIGATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Description of Event or Problem · 1
COMPLAINT INVESTIGATOR REPORTED THAT A DRILL BARREL SEEMED TO BE BLOCKED. WHILE DRILLING, PLASTIC WAS ESCAPING UP THE BARREL ALONG THE DRILL AND BARREL DISLODGE FROM GUIDE. NO ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 801676 | JAWS NITINOL STAPLE SYSTEM | JAWS STAPLE SYSTEM, DRILL GUIDE STRAIGHT, 2.3MM, 18MM | JDR | PARAGON 28, INC. | P70-941-2318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | P50-353-3512 (X3).| P50-353-3516 (X1).| P50-353-3518 (X1).| P50-353-3522 (X2).| P50-353-3524 (X1).| P50-453-3518 (X1).| P50-453-3522 (X1).| P53-110-L002 (X1).| P53-110-L302 (X1).| P71-018-1818-S (X1).| P99-100-2009 (X1).| P99-100-2414 (X1).| P99-192-1615 (X3).| P99-200-1406 (X1). |