MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-07-25 for CHISEL-HANDLE 399.540 manufactured by Synthes Gmbh.
[3617519]
Device report from synthes (b)(6) reports an event in (b)(6) as follows: during a procedure on (b)(6) 2013, the chisel handle broke during surgery while being used on a patient. No additional information is available. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10962720]
Device was used for treatment, not diagnosis. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn. The device history record is not available as the device was manufactured more than 10 years ago.
Patient Sequence No: 1, Text Type: N, H10
[26276656]
An investigation was conducted and it states that the instrument had a broken handle made from canevasit that was partially worn out and the shaft had discolorations. No manufacturing related issues that would have contributed to this complaint were found. Since this was an old instrument, it was concluded that repeated high temperature cycles during sterilization processes have led to brittleness of the canevasit resulting in the breakage of the handle.
Patient Sequence No: 1, Text Type: N, H10
[26276657]
This is 1 of 1 report for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2013-04472 |
| MDR Report Key | 3246679 |
| Report Source | 01,07 |
| Date Received | 2013-07-25 |
| Date of Report | 2013-05-28 |
| Date of Event | 2013-05-28 |
| Date Mfgr Received | 2013-09-09 |
| Date Added to Maude | 2013-10-22 |
| 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 | ADAM SHUKUR |
| 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 | 2013-07-25 |
| Returned To Mfg | 2013-07-04 |
| Catalog Number | 399.540 |
| Lot Number | 2081 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-07-25 |