MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-21 for HAMMERTUBE SYSTEM P40-001-0275-S manufactured by Paragon 28, Inc..
[188694131]
The device is 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.
Patient Sequence No: 1, Text Type: N, H10
[188694132]
It was reported that the patient underwent a hammertoe surgical procedure that utilized a 2. 75mm straight hammertube implant. The original surgery occurred on (b)(6) 2019. Per surgeon instruction, the patient was weight-bearing in a boot immediately post-operatively. The implant broke 2-3 weeks postoperatively, but the exact date is unknown. There is no reported delayed union of the patient's joint or patient noncompliance. The implant was revised on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008650117-2020-00007 |
| MDR Report Key | 9742260 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-21 |
| 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 | HAMMERTUBE SYSTEM |
| Generic Name | INTERPHALANGEAL IMPLANT |
| Product Code | HTY |
| Date Received | 2020-02-21 |
| Model Number | P40-001-0275-S |
| Catalog Number | P40-001-0275-S |
| Lot Number | 26012971902 |
| 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 | 2020-02-21 |