MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,company representati report with the FDA on 2015-02-10 for SMALL-AIR-DRILL F/SINGLEAIRHOSES 511.100 manufactured by Depuy Synthes Power Tools.
[5532001]
It was reported from (b)(6) that the small air drill device did function. It was not reported if the device was used in surgery, or if there was patient involvement. It was not reported if there were any delays in a surgical procedure or if a spare device was available. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. The exact date of this event was unknown. 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
[12840217]
(b)(6). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[26626528]
Additional narrative: the actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the device was worn out. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to wear from normal use and servicing. If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009450871-2015-10213 |
| MDR Report Key | 4504955 |
| Report Source | 01,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-02-10 |
| Date of Report | 2015-01-20 |
| Date Mfgr Received | 2015-09-18 |
| Device Manufacturer Date | 2015-01-21 |
| Date Added to Maude | 2015-03-12 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | HAUPTSTRASSE 24 |
| Manufacturer City | WALDENBURG CH4437 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMALL-AIR-DRILL F/SINGLEAIRHOSES |
| Generic Name | INSTRUMENT, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2015-02-10 |
| Returned To Mfg | 2015-02-05 |
| Catalog Number | 511.100 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | HAUPTSTRASSE 24 WALDENBURG CH4437 SZ CH4437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-10 |