MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-21 for CHISEL-FLAT-STRAIGHT W/8 397.970 manufactured by Synthes Gmbh.
[17839089]
It was reported the chisel broken during a total knee replacement surgery. The instrument was only used for one year before it broke. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18247913]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. A review of the device history records was performed and no complaint related issues were found. The additional evaluation revealed that the chisel is broken, and all pieces are available. The microscopic view of the broken surfaces does not show any anomalies of materials structure. The measurable dimensions were checked and found to be in compliance with the technical drawings and ao/asif specification. Further investigation on the available broken off part shows that the blade is blunt is even was damaged on one half. Probably the blade got in contact with metallic parts. Instruments have to be checked and replaced during and mainly after surgeries if there are initial damages or wear. It is possible that instruments have to be replaced even after first surgery if there is any wear or damage. Please consider our general guidelines for reprocessing, care and maintenance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-03436 |
| MDR Report Key | 3183017 |
| Report Source | 01,07 |
| Date Received | 2013-06-21 |
| Date of Report | 2011-06-21 |
| Date Mfgr Received | 2011-06-21 |
| Device Manufacturer Date | 2009-10-01 |
| Date Added to Maude | 2013-09-16 |
| 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 | T. MCCARRON |
| 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-FLAT-STRAIGHT W/8 |
| Product Code | EML |
| Date Received | 2013-06-21 |
| Catalog Number | 397.970 |
| Lot Number | 2519482 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-06-21 |