MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-17 for APPLIC-INSTR W/ALIGNMENT GUIDE F/FLAPFIX 329.323 manufactured by Synthes Gmbh.
[20005018]
It was reported that the fixation set screw was detached from the application instrument. No further information was provided. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20167344]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. The device listed in this report is used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Actual event date not known. The device was returned for inspection and the event was confirmed. The investigation of the complained application instrument found that the holding pin of the adjusting bar broke in half. We are not able to reliably determine the reason why and we suppose that a mechanical overloading situation led to the damage. A review of the dhr indicates there were no anomalies which could have caused or contributed to this complaint. The manufacturing records were reviewed and no complaint related issues were found. All records indicate the product was manufactured to specifications. Conclusion: the complaint is considered indeterminate from a manufacturing perspective as no product fault could be detected. While we suppose that a mechanical overloading situation led to the damage, we are not able to determine the exact cause of this occurrence and the complaint condition remains unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-03454 |
| MDR Report Key | 3174023 |
| Report Source | 01,07 |
| Date Received | 2013-06-17 |
| Date of Report | 2012-08-16 |
| Date Mfgr Received | 2012-08-16 |
| Device Manufacturer Date | 2011-02-11 |
| Date Added to Maude | 2013-09-11 |
| 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 | APPLIC-INSTR W/ALIGNMENT GUIDE F/FLAPFIX |
| Product Code | HXQ |
| Date Received | 2013-06-17 |
| Catalog Number | 329.323 |
| Lot Number | 3690446 |
| 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 | 2013-06-17 |