MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2007-02-02 for LATERAL TRACTION CLARK AR-1620C manufactured by Arthrex, Inc..
[595133]
When mounting the lateral traction device, the screw got stuck and could not be used. The customer used another traction device and the surgery was delayed over 30 minutes. No adverse consequences were reported as a result of this event. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[7923674]
Device evaluation confirmed that upon return, the screw was stuck to the lateral traction clamp that affixes device to clark rail. The knob was removed and lubricated and the device now functions properly. The event reported may occur if the knob is impacted, during handling and/or due to insufficient maintenance of the parts. This event was attributed to misuse.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2007-00011 |
| MDR Report Key | 818043 |
| Report Source | 01,06,08 |
| Date Received | 2007-02-02 |
| Date of Report | 2007-01-31 |
| Date of Event | 2006-12-07 |
| Date Mfgr Received | 2007-01-10 |
| Date Added to Maude | 2007-02-20 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | IVETTE GALMEZ, SENIOR ANALYST |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LATERAL TRACTION CLARK |
| Generic Name | LIMB POSITIONER |
| Product Code | ILZ |
| Date Received | 2007-02-02 |
| Returned To Mfg | 2007-01-26 |
| Model Number | NA |
| Catalog Number | AR-1620C |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 805527 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | * NAPLES FL * US |
| Baseline Brand Name | LATERAL TRACTION CLARK |
| Baseline Generic Name | LIMB POSITIONER |
| Baseline Model No | NA |
| Baseline Catalog No | AR-1620C |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-02 |