MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-02 for DRILL/REAMER 72204091 manufactured by Smith & Nephew, Inc..
[47590019]
No evaluation conducted to date, awaiting receipt of device. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[47590020]
It was reported that during a procedure, the device would not power on. There was no backup device available and a competitor's device was used to complete the procedure. No patient injury or complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[51193252]
Examination was not possible, as the device was not returned. The investigation was limited to the information provided. The investigation could not draw any conclusions about the reported event. No further investigation is warranted at this time. A review of the device history record was performed which confirmed no inconsistencies.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003604053-2016-00019 |
| MDR Report Key | 5694857 |
| Date Received | 2016-06-02 |
| Date of Report | 2016-05-09 |
| Date of Event | 2016-05-09 |
| Date Mfgr Received | 2016-08-02 |
| Device Manufacturer Date | 2016-03-04 |
| Date Added to Maude | 2016-06-02 |
| 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 | JAMES GONZALES |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRILL/REAMER |
| Generic Name | SAW, PNEUMATICALLY POWERED |
| Product Code | KFK |
| Date Received | 2016-06-02 |
| Catalog Number | 72204091 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-02 |