MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-13 for TURNKEY FCS FCS-400 manufactured by Hand Biomechanics Lab, Inc.
[94699644]
Determined device event from 1 of 9 possible device lots. Reviewed sterilization and sterilie barrier inspection records for all 9 lots. No pattern related to irradiation dose lot or device lot was noted. Confirmed labeling included warning and cautions regarding pin site care.
Patient Sequence No: 1, Text Type: N, H10
[94699645]
Physician reported a patient once had a pin site 'infection from side to side movement of the transverse pin through the bone'.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919128-2017-00003 |
| MDR Report Key | 7113183 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-13 |
| Date of Report | 2018-12-14 |
| Date of Event | 2015-09-11 |
| Date Mfgr Received | 2015-09-11 |
| Date Added to Maude | 2017-12-13 |
| 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 | MR DUSTIN DEQUINE |
| Manufacturer Street | 77 SCRIPPS DRVIE, SUITE 104 |
| Manufacturer City | SACRAMENTO CA 95825 |
| Manufacturer Country | US |
| Manufacturer Postal | 95825 |
| Manufacturer Phone | 9169235073 |
| Manufacturer G1 | HAND BIOMECHANICS LAB, INC. |
| Manufacturer Street | 77 SCRIPPS DRIVE, SUITE 104 |
| Manufacturer City | SACRAMENTO CA 95825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TURNKEY FCS |
| Generic Name | TURNKEY FCS |
| Product Code | JEC |
| Date Received | 2017-12-13 |
| Model Number | FCS-400 |
| Catalog Number | FCS-400 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAND BIOMECHANICS LAB, INC |
| Manufacturer Address | 77 SCRIPPS DRIVE, SUITE 104 SACRAMENTO CA 95825 US 95825 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-13 |