MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for JAWS NITINOL STAPLE SYSTEM P71-020-2020-S manufactured by Paragon 28, Inc..
[188695146]
This is the second of two reports (see 3008650117-2020-00012) in relation to the report of two broken staples. During evaluation and investigation, the implants were not available for analysis. The implants are not expected to be returned for the manufacturer review/investigation. The device history records were reviewed and showed that parts were manufactured and inspected within all critical specifications of the device manufacturing record. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[188695147]
It was reported that a paragon 28 jaws 20mm staple was implanted for a talonavicular fusion. The staple broke post-operatively at the junction of the staple bridge and leg. The broken staple was revised. The revision date, patient information, and information regarding the patient health after the implant breakage was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008650117-2020-00013 |
| MDR Report Key | 9892160 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MACKENZIE BELDEN |
| Manufacturer Street | 14445 GRASSLANDS DR. |
| Manufacturer City | ENGLEWOOD, CO |
| Manufacturer Country | US |
| Manufacturer Phone | 6431300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAWS NITINOL STAPLE SYSTEM |
| Generic Name | BONE STAPLE |
| Product Code | JDR |
| Date Received | 2020-03-27 |
| Model Number | P71-020-2020-S |
| Catalog Number | P71-020-2020-S |
| Lot Number | 260305118A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARAGON 28, INC. |
| Manufacturer Address | 14445 GRASSLANDS DR. ENGLEWOOD, CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |