MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-01-02 for L-CURETTE MED 356.619 manufactured by Synthes Gmbh.
[21050928]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: a male patient, (b)(6) years of age, was admitted with a multi-fragment fracture of mid distal third of the right tibia and fibula. A utn 8x 315mm l nail was implanted. While cleaning, there was an anterior contact with the nail of the curette or mid l-spacer and the tip of the nail broke down. It was impossible to remove it from the patient. The specialist decided to continue the procedure drilling and locking the mid lateral distal holes with two 3. 9x 30 and 32mm l locking screws. The surgeon verified the reduction, lock and stability of the fixation using the image intensifier. The wound was washed, reviewed and closed. The surgery was completed with no further complications. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21140897]
Device was used for treatment, not diagnosis. Implant, explant dates: device is an instrument and is not implanted/explanted. Device is not distributed in the united states, but is similar to device marketed in the usa. The device history records was not available as device is older than 15 years. Subject device has been received and is currently in the evaluation process. Investigation is on going; no conclusion could be drawn. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-05604 |
| MDR Report Key | 3546212 |
| Report Source | 01,07 |
| Date Received | 2014-01-02 |
| Date of Report | 2013-08-05 |
| Date of Event | 2013-07-29 |
| Date Mfgr Received | 2013-08-05 |
| Device Manufacturer Date | 1997-06-10 |
| Date Added to Maude | 2014-04-04 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | W. LINDENMUTH |
| 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 | L-CURETTE MED |
| Product Code | HTF |
| Date Received | 2014-01-02 |
| Returned To Mfg | 2013-12-06 |
| Catalog Number | 356.619 |
| Lot Number | 1003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-01-02 |