MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-20 for CHISEL-FLAT-STRAIGHT W/8 397.970 manufactured by Synthes Gmbh.
[3518254]
It was reported that the chisel broke during a total knee replacement surgery. The chisel was being used on periprosthetic cement. Product only used less than one year and was broken. Customer complained that the product is not durable. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10747331]
Additional narrative: 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 evaluation revealed that the blade of the chisel was partially broken off. All articles have been distributed worldwide and we are not aware off any other similar breakages related to the mentioned lot number. The microscopic view of the broken surfaces does not show any anomalies of material structure. The measurable dimensions were checked and found to be in compliance with the technical drawings and ao asif specification. The instrument meets fully to our specifications. No product fault could be detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-03694 |
| MDR Report Key | 3180699 |
| Report Source | 01,07 |
| Date Received | 2013-06-20 |
| Date of Report | 2011-08-03 |
| Date Mfgr Received | 2011-08-03 |
| Device Manufacturer Date | 2011-05-16 |
| Date Added to Maude | 2013-09-13 |
| 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 |
| 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 | 2013-06-20 |
| Catalog Number | 397.970 |
| Lot Number | 2715973 |
| 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 | 2013-06-20 |