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 2018-12-14 for DOUBLEAIRHOSE L5M F/SYST SYNTHES 519.530 manufactured by Depuy Synthes Products Llc.
[130475388]
Device was used for treatment, not diagnosis. Udi: lot/serial unknown. (b)(4). Device manufacture date: the device manufacture date is unavailable. The manufacturing location was unknown. 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
[130475389]
It was reported from (b)(6) that during a osteosynthesis surgical procedure for the femoral trochanteric fracture with tfn-advanced proximal femoral nailing system (tfna) and compact air drive (cad) device it was observed that the double air hose device ruptured, and the cad was unable to be used for drilling. It was reported that the procedure was completed successfully by using an unspecified spare power tool (zimmer device) in the hospital. It was reported that there was a less than 30-minute delay in the procedure due to the event. There was patient involvement reported. 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 will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-59050 |
| MDR Report Key | 8166656 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-14 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-11-28 |
| Date Mfgr Received | 2018-11-28 |
| Date Added to Maude | 2018-12-14 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | N/I |
| Manufacturer Street | N/I |
| Manufacturer City | N/I N/I |
| Manufacturer Postal Code | N/I |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLEAIRHOSE L5M F/SYST SYNTHES |
| Generic Name | INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2018-12-14 |
| Catalog Number | 519.530 |
| Lot Number | N/I |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-14 |