MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-09-14 for ARTHROSURFACE TOEMOTION 4P09-2000 manufactured by Arthrosurface, Inc..
[86148404]
A review of device history record of the suspect lot indicated all parts were built to specification. The reamer in question was reviewed by the engineering department. Slight normal wear and tear from general use of the instrument is visible. The investigation concluded that the reamer is still functional and satisfies the intended purpose. There is no evidence that the reamer had actually contributed to the reported phalangeal fracture. The outcome of a case depends on several factors such as surgeon's operating technique, patient factors like age, bone density, clinical history etc. , this is the first complaint of this type and arthrosurface will continue to monitor.
Patient Sequence No: 1, Text Type: N, H10
[86148405]
A patient's phalangeal bone was fractured while preparing the implant site with an arthrosurface reamer. The surgeon was curious if the reamer was dull.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2017-00016 |
| MDR Report Key | 6865167 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-09-14 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-08-15 |
| Date Mfgr Received | 2017-08-15 |
| Date Added to Maude | 2017-09-14 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PHANI PUPPALA |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal | 02038 |
| Manufacturer Phone | 5085203003 |
| Manufacturer G1 | PRIMO MEDICAL GROUP |
| Manufacturer Street | 75 MILL ST |
| Manufacturer City | STOUGHTON MA 02072 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHROSURFACE TOEMOTION |
| Generic Name | ARTHROSURFACE? TOTAL TOE - PROXIMAL PHALANX IMPLANT |
| Product Code | LZJ |
| Date Received | 2017-09-14 |
| Returned To Mfg | 2017-09-07 |
| Model Number | 4P09-2000 |
| Lot Number | 75HE0708R |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROSURFACE, INC. |
| Manufacturer Address | 28 FORGE PARKWAY FRANKLIN MA 02038 US 02038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-14 |