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 2017-05-24 for DOUBLE AIR HOSE SCHRADER STEM 3 METERS 519.51S manufactured by Depuy Synthes Power Tools.
[75824249]
(b)(4). 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
[75824250]
It was reported that during an unspecified surgical procedure right before the surgeon used the double air hose device, it was noted that the there was an air leak from the crack in the hose. According to the reporter, the device was not "function tested" during set up prior to use; therefore, they were unable to detect where the leak was coming from the hose. There were no delays to the planned surgical procedure. A spare device was used to complete the procedure successfully. There were no reports of 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
[79166623]
The actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the inner hose was pulled from the plug causing it to leak. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to component damage from improper handling. 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 | 8030965-2017-12539 |
| MDR Report Key | 6587004 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-04 |
| Date of Event | 2017-05-04 |
| Date Mfgr Received | 2017-05-22 |
| Date Added to Maude | 2017-05-24 |
| 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 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | N/I |
| Manufacturer City | N/I |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLE AIR HOSE SCHRADER STEM 3 METERS |
| Generic Name | INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2017-05-24 |
| Returned To Mfg | 2017-05-11 |
| Catalog Number | 519.51S |
| Lot Number | 0 |
| 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 | N/I N/I US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-24 |