MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-02-18 for MTATARSAL SURFACE REAMER SZ. 30/40 MSR-890-30/40 manufactured by Ascension Orthopedics.
[21803928]
This is the first report of two reports concerning the same pt surgery. This report concerns the metatarsal surface reamer sc. 30/40 (msr-890-30/40). It was reported the surgeon used the movement set for a total metatarsal phalangeal joint (mpj) placement. The surgeon had difficulty with the metatarsal reamer 30/40 size and with the phalanx reamer 10/20. The devices seemed dull and they did not ream the bone. Back up reamer was not available. The surgeon used a burr to complete the surgery. The surgery time was extended 45 minutes. There was no injury to the pt alleged.
Patient Sequence No: 1, Text Type: D, B5
[22010326]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2014-00009 |
| MDR Report Key | 3770730 |
| Report Source | 05,07 |
| Date Received | 2014-02-18 |
| Date of Report | 2014-01-24 |
| Date of Event | 2014-01-24 |
| Date Mfgr Received | 2014-02-05 |
| Date Added to Maude | 2014-05-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTATARSAL SURFACE REAMER SZ. 30/40 |
| Generic Name | MOVEMENT GREAT TOE INSTRUMENTS |
| Product Code | KWF |
| Date Received | 2014-02-18 |
| Catalog Number | MSR-890-30/40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-18 |