MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-03-05 for CHISEL HANDLE 399.54 manufactured by Synthes Gmbh.
[16376312]
Device was 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
[16597642]
During an unknown surgery on (b)(6) 2013, the wooden handle of a chisel cracked and one piece fell onto the floor. Surgery was not prolonged and no adverse effect to the patient reported. This is 1 of 1 report for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2013-00734 |
| MDR Report Key | 2989061 |
| Report Source | 05,07 |
| Date Received | 2013-03-05 |
| Date of Report | 2013-02-05 |
| Date of Event | 2013-02-04 |
| Date Mfgr Received | 2013-02-05 |
| Device Manufacturer Date | 2001-12-04 |
| Date Added to Maude | 2013-05-13 |
| 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 | KUBA ZAROBKIEWICZ |
| 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 | CHISEL HANDLE |
| Product Code | EML |
| Date Received | 2013-03-05 |
| Catalog Number | 399.54 |
| Lot Number | 2018079 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-03-05 |