MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-17 for DOUBLEAIRHOSE L3M F/SYST-SYNTHES 519.510 manufactured by Synthes ?sterreich Gmbh (produktion).
[93175573]
(b)(4). 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
[93175574]
It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the double air hose device burst before use and had an intense noise. It was not reported if there were any delays in the surgical procedure or if a spare device was available. There was patient involvement reported. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. 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 | 8030965-2017-50029 |
| MDR Report Key | 7041918 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-17 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-10-25 |
| Date Mfgr Received | 2018-01-09 |
| Device Manufacturer Date | 2008-03-25 |
| Date Added to Maude | 2017-11-17 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLEAIRHOSE L3M F/SYST-SYNTHES |
| Generic Name | INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2017-11-17 |
| Returned To Mfg | 2017-11-03 |
| Catalog Number | 519.510 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES ?STERREICH GMBH (PRODUKTION) |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-17 |