MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-03-08 for CURVED PELVIC OSTEOTOME 20MM WIDTH 03.100.039 manufactured by Synthes Gmbh.
[3198829]
During peri osteotomy operation on (b)(6) 2013, the chisel broke off at the handle and disconnected from the rest of the chisel. The chisel was stuck in the bone and they had to use another device to get it out. No adverse effect to the patient was reported. Surgery prolonged approximately 10 to 15 minutes. Sales consultant was not in the or and was told by the coordinator.
Patient Sequence No: 1, Text Type: D, B5
[10522413]
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process. Investigation is on going; no conclusion could be drawn. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-00752 |
| MDR Report Key | 2995394 |
| Report Source | 05,07 |
| Date Received | 2013-03-08 |
| Date of Report | 2013-02-07 |
| Date of Event | 2013-01-28 |
| Date Mfgr Received | 2013-02-07 |
| Device Manufacturer Date | 2009-03-10 |
| Date Added to Maude | 2013-05-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICOLE GAMBLE |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURVED PELVIC OSTEOTOME 20MM WIDTH |
| Generic Name | OSTEOTOME |
| Product Code | EMM |
| Date Received | 2013-03-08 |
| Returned To Mfg | 2013-02-21 |
| Catalog Number | 03.100.039 |
| Lot Number | T934535 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Required No Informationntervention | 2013-03-08 |