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 2017-02-09 for DOUBLEAIRHOSE L3M F/SYST-SYNTHES 519.510 manufactured by Synthes Oberdorf.
[67210370]
(b)(4). (b)(6). The actual device has been returned and is currently pending evaluation. Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly. 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
[67210371]
It was reported from (b)(6) that during an unspecified surgery, it was observed that the air hose device was leaking air from the hose. It was not reported if there was a delay to the surgical procedure or whether a spare device was available for use. There was patient involvement reported. There were no 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
[74805980]
Additional narrative: the actual device was returned for evaluation. Reliability engineering evaluated the device, observed that the device passed all manufacturing specifications and identified no failure. Therefore, the reported condition was not duplicated and confirmed. An assignable root cause was not determined. 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
| Report Number | 8030965-2017-10693 |
| MDR Report Key | 6314140 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-09 |
| Date of Report | 2017-01-23 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2003-09-04 |
| Date Added to Maude | 2017-02-09 |
| 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 OBERDORF |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF CH4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4436 |
| 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 | 2017-02-09 |
| Returned To Mfg | 2017-01-24 |
| Catalog Number | 519.510 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES OBERDORF |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF CH4436 SZ CH4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-09 |