MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2005-05-09 for CORTICAL SCREW 2.3 X 22 MM, HEX 1.5 MM, TITANIUM AR-13120T-22 manufactured by Arthrex, Inc..
[389095]
Screw broke while it was approx half way inserted at the fifth thread down from the head. The surgeon stated that it broke due to a torsional load. The lot number was not provided and it is unk if the implant broken was part # ar-13120t-22 or ar-13120t-24. It was reported that the tip of the implant could not be retrieved and was left securely in the pt's bone. Surgeon reported no adverse consequences as a result of event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2005-00081 |
| MDR Report Key | 600571 |
| Report Source | 06,07 |
| Date Received | 2005-05-09 |
| Date of Report | 2005-05-02 |
| Date of Event | 2005-04-22 |
| Date Mfgr Received | 2005-04-27 |
| Date Added to Maude | 2005-05-11 |
| 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 SOTOMAYOR, MDR COORDINATR |
| Manufacturer Street | 1370 CREEKSIDE BLVD |
| 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 | CORTICAL SCREW 2.3 X 22 MM, HEX 1.5 MM, TITANIUM |
| Generic Name | PLATE SCREW |
| Product Code | HWL |
| Date Received | 2005-05-09 |
| Model Number | AR-13120T-22 |
| Catalog Number | AR-13120T-22 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 590406 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | * NAPLES FL * US |
| Baseline Brand Name | CORTICAL SCREW 2.3 X 22 MM, HEX 1.5 MM, TITANIUM |
| Baseline Generic Name | PLATE SCREW |
| Baseline Model No | AR-13120T-22 |
| Baseline Catalog No | AR-13120T-22 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-09 |