MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2007-08-28 for BLUNT OBTURATOR, 3.5MM C3253 manufactured by Conmed Linvatec.
[681781]
It was reported that during use of this obturator in a wrist arthroscopy procedure, metal shavings were observed in the joint. The surgeon flushed the shavings, however, it is unk if all metal shavings were removed from the joint. There was no report of pt injury with this event.
Patient Sequence No: 1, Text Type: D, B5
[7863212]
Investigation findings: the device has been received for evaluation, however, the eval is still in process. A follow-up report will be submitted with the investigation findings. This is the first report of this failure mode for this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028292-2007-00008 |
| MDR Report Key | 905367 |
| Report Source | 05,06,07 |
| Date Received | 2007-08-28 |
| Date of Report | 2007-08-02 |
| Date Mfgr Received | 2007-08-02 |
| Date Added to Maude | 2007-11-13 |
| 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 | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | HENKE-SASS WOLF, GMBH |
| Manufacturer Street | KRONENTRASSE 16 |
| Manufacturer City | TUTTLINGEN, BADEN-WURTTEMBERG 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLUNT OBTURATOR, 3.5MM |
| Generic Name | OBTURATOR |
| Product Code | FEC |
| Date Received | 2007-08-28 |
| Returned To Mfg | 2007-08-14 |
| Model Number | NA |
| Catalog Number | C3253 |
| Lot Number | 400045 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 911351 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-28 |