MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-08-27 for AO REDUCTION DRIVE UNIT 532.017 manufactured by Synthes Gmbh.
[3642647]
It was reported that during a trochanteric fixation nail surgery to address a right hip fracture, an ao reduction drive unit would not reverse. The surgery was completed successfully using a spare ao reduction drive unit. There was reportedly no delay in surgery, no injury, and no medical intervention due to the alleged incident. Patient post-operative condition is stable. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11013608]
Device used for treatment, not diagnosis. The investigation could not be completed; no conclusion could be drawn, as no product was received. The manufacturing documents were reviewed and no complaint related issues were found.
Patient Sequence No: 1, Text Type: N, H10
[21663678]
Device was used for treatment, not diagnosis. Additional narrative: a service history of the past six months has been reviewed. No service history review can be performed. The item has not been sent in for service. There is no information relevant to the current complained issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-04690 |
| MDR Report Key | 3311690 |
| Report Source | 05,07 |
| Date Received | 2013-08-27 |
| Date of Report | 2013-07-29 |
| Date of Event | 2013-07-25 |
| Date Mfgr Received | 2014-05-14 |
| Device Manufacturer Date | 2010-06-08 |
| Date Added to Maude | 2013-11-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AO REDUCTION DRIVE UNIT |
| Product Code | GFC |
| Date Received | 2013-08-27 |
| Catalog Number | 532.017 |
| Lot Number | MA1067 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-27 |