MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-11-16 for RIA DRIVESHAFT L520 314.743 manufactured by Synthes Gmbh.
[17753956]
A review of synthes device history records was conducted. This supplier lot number was received and inspected to the synthes incoming final inspection.
Patient Sequence No: 1, Text Type: N, H10
[21668705]
Device report from (b)(6) reports an event in (b)(6) as follows: the threads at the tip of the ria drive shafts sheared off. Reportedly all parts could be removed. This is 3 of 3 reports for the same event.
Patient Sequence No: 1, Text Type: D, B5
[21886902]
Device was used for treatment. The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system. A review of the device history records has been requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2012-01270 |
| MDR Report Key | 2835315 |
| Report Source | 01,07 |
| Date Received | 2012-11-16 |
| Date of Report | 2012-10-17 |
| Date Mfgr Received | 2012-10-17 |
| Date Added to Maude | 2013-02-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SARMA PIN |
| 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 | RIA DRIVESHAFT L520 |
| Generic Name | RIA DRIVESHAFT |
| Product Code | GFC |
| Date Received | 2012-11-16 |
| Returned To Mfg | 2012-11-12 |
| Catalog Number | 314.743 |
| Lot Number | 14780-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-11-16 |