MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-01-08 for COMPRESSION/DISTRACTION DEVICE F/FOOT+AN 03.111.021 manufactured by Synthes Gmbh.
[3057817]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: the end cap of the compression/distraction device is loose and the slide cannot be moved in control.
Patient Sequence No: 1, Text Type: D, B5
[10393441]
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system. The manufacturing documents were reviewed and no complaint related issues were found.
Patient Sequence No: 1, Text Type: N, H10
[10518381]
Additional narrative:(b)(4). Device used for treatment and not diagnosis. Additional information. The performed investigation has shown that the sealing cap has been loosened at the wing nuts. The cap of the wing nut was not sent for investigation. Therefore, we can not comprehend the exact cause for this adverse event afterwards. However, we can only assume that the cap could not withstand the load effects, which finally led to the failure of the joint due to material strain, fatigue. (b)(4): placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-00062 |
| MDR Report Key | 2900744 |
| Report Source | 01,07 |
| Date Received | 2013-01-08 |
| Date of Report | 2012-12-10 |
| Date Mfgr Received | 2013-02-04 |
| Device Manufacturer Date | 2011-03-08 |
| Date Added to Maude | 2013-04-01 |
| 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 | SHERRY LAING |
| 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 | COMPRESSION/DISTRACTION DEVICE F/FOOT+AN |
| Generic Name | COMPRESSION/DISTRACTION DEVICE |
| Product Code | JEC |
| Date Received | 2013-01-08 |
| Returned To Mfg | 2012-12-17 |
| Catalog Number | 03.111.021 |
| Lot Number | T956248 |
| 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 | 2013-01-08 |