MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2002-08-30 for ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LAG SCREW 00225700142 manufactured by Zimmer, Inc..
[260632]
Surgeon implanted an itst asis (short) nail in patient. Patient fell 2-3 weeks after surgery and fractured femoral shaft at level of distal locking screw. Nail was removed and a longer length itst nail was implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2002-00105 |
| MDR Report Key | 413922 |
| Report Source | 01,05,07 |
| Date Received | 2002-08-30 |
| Date of Report | 2002-07-31 |
| Date of Event | 2002-07-05 |
| Date Facility Aware | 2002-07-31 |
| Report Date | 2002-07-31 |
| Date Mfgr Received | 2002-07-31 |
| Date Added to Maude | 2002-09-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CONNIE MORGAN, MANAGER |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5743724269 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LAG SCREW |
| Generic Name | LAG SCREW |
| Product Code | NDE |
| Date Received | 2002-08-30 |
| Returned To Mfg | 2002-08-02 |
| Model Number | NA |
| Catalog Number | 00225700142 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 402961 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Baseline Brand Name | ITST INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LEG SCREW |
| Baseline Generic Name | LAG SCREW |
| Baseline Model No | NA |
| Baseline Catalog No | 00225700142 |
| Baseline ID | NA |
| Baseline Device Family | ITST FIXATION |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2002-08-30 |