MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-03 for BONE COLLECTOR B-COLLECTOR-1 manufactured by Depuy Synthes Power Tools.
[46393546]
The device has not been returned as this is a single-use instrument; therefore, the reported condition cannot be confirmed and/or duplicated. If additional information should become available, a supplemental medwatch report will be sent accordingly. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[46393547]
It was reported that during a mastoid obliteration surgical procedure the bone collector device "was not collecting as much as usual. " according to the reporter, the user tried to level the device and hold the device according to labeling instructions. The reporter also stated that the user tried to change the chamber. After applying the changes, the device collected more but still was not collecting as much as usual. It was unknown to the reporter if there were any delays in a surgical procedure or if a spare device was available. No patient harm, adverse outcome or injury was alleged. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045834-2013-02695 |
| MDR Report Key | 5690863 |
| Date Received | 2013-07-03 |
| Date of Report | 2013-06-03 |
| Date of Event | 2013-06-03 |
| Date Mfgr Received | 2013-06-03 |
| Device Manufacturer Date | 2013-01-15 |
| Date Added to Maude | 2016-06-01 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR RODNEY CRAIN |
| Manufacturer Street | 4500 RIVERSIDE DR. |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5614943766 |
| Manufacturer G1 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | 4500 RIVERSIDE DR. |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONE COLLECTOR |
| Generic Name | BONE PARTICLE COLLECTOR |
| Product Code | MXP |
| Date Received | 2013-07-03 |
| Catalog Number | B-COLLECTOR-1 |
| Lot Number | F533073485 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | 4500 RIVERSIDE DR. PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-03 |