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 2017-07-26 for DOUBLEAIRHOSE L3M F/SYST-SYNTHES 519.510 manufactured by Umkirch.
[81008350]
(b)(4). The actual device has been returned and is currently pending evaluation. Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
Patient Sequence No: 1, Text Type: N, H10
[81008351]
It was reported from (b)(6) that during a femoral diaphyseal spiral fracture surgical procedure, during drilling the hole for bone fenestration before inserting the blade, it was observed that the hose burst on the compact air drive device. According to the report, there was a? Huge explosion sound? And air was leaking. There was a one minute delay to the surgical procedure as a result of the event. It was reported that a spare device was available for use to complete the procedure safely. The reporter stated that the device was checked postoperatively, and it was observed that the pressure of nitrogen for equipment in the operating room was set to 140 pounds per square inch(psi), when the recommended operation pressure was supposed to be 87 psi. There was patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. All the available information has been disclosed. If any additional information should become available, this record will be updated accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2017-13858 |
| MDR Report Key | 6743418 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-26 |
| Date of Report | 2017-07-04 |
| Date of Event | 2017-07-04 |
| Date Mfgr Received | 2017-07-27 |
| Device Manufacturer Date | 2004-08-11 |
| Date Added to Maude | 2017-07-26 |
| 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 | UMKIRCH |
| Manufacturer Street | IM KIRCHENHURSTLE 4 NI |
| Manufacturer City | UMKIRCH B. FREIBURG D-79224 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79224 |
| 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 | 2017-07-26 |
| Returned To Mfg | 2017-07-19 |
| 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 | UMKIRCH |
| Manufacturer Address | IM KIRCHENHURSTLE 4 UMKIRCH B. FREIBURG D-79224 GM D-79224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-26 |