MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-08-28 for COMPR WIRE 1.6 L150/25 03.211.425.01S manufactured by Synthes Gmbh.
[16325605]
No product fault could be detected. We found that the wire is broken at the threaded part about 4mm below the ball. The thread flanks at the broken fragment are badly damaged, but afterwards it can not be defined if this damage was caused during the insertion or during the extraction of the fragment. The exact cause of this occurrence can not be defined. Based on the appearance of the fracture face and the stress marks at the wire above the ball we can only assume that a mechanical overload caused this breakage. The manufacturing documents were reviewed and no complaint related issues were found.
Patient Sequence No: 1, Text Type: N, H10
[17561407]
Patient was undergoing a procedure on the 3rd metatarsal. The surgeon used a compression wire per the surgical technical perpendicular to a 3 hold plate. He drilled through the first cortex and as it penetrated the second cortex to apply compression the wire broke at the junction below the olive. The surgeon had to split the metatarsal to remove the wire as it was protruding too much through the second cortex to leave it in. The procedure was extended about 45 minutes and was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[17670540]
Investigation is ongoing. Device has been received and is currently in the evaluation. No conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2012-00700 |
| MDR Report Key | 2722202 |
| Report Source | 01,07 |
| Date Received | 2012-08-28 |
| Date of Report | 2012-08-02 |
| Date of Event | 2012-08-01 |
| Date Mfgr Received | 2012-10-03 |
| Date Added to Maude | 2012-09-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JODI TEMPLE |
| 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 |
| Manufacturer City | OBERDORF CH-4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPR WIRE 1.6 L150/25 |
| Generic Name | COMPR WIRE 16. L150/25 |
| Product Code | HXS |
| Date Received | 2012-08-28 |
| Returned To Mfg | 2012-08-21 |
| Catalog Number | 03.211.425.01S |
| Lot Number | 3681401 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | OBERDORF CH-4436 CH-4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-28 |