MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-05-24 for PASSPORT A/R FEM. ALIGN. GUIDE 7650-5901 manufactured by Stryker Orthopaedics Mahwah.
[1539982]
Scorpio replacement instrument issue: the anterior skim cutting guide was loose in the a/r femoral alignment guide and was unable to be tightened to hold. Replacement instruments being used for the first time.
Patient Sequence No: 1, Text Type: D, B5
[8554665]
A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2249697-2010-00580 |
| MDR Report Key | 1701372 |
| Report Source | 01,07 |
| Date Received | 2010-05-24 |
| Date of Report | 2010-05-11 |
| Date of Event | 2010-05-11 |
| Date Mfgr Received | 2010-05-11 |
| Device Manufacturer Date | 2009-11-12 |
| Date Added to Maude | 2010-11-18 |
| 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 | JADWIGA DEGRADO |
| Manufacturer Street | 325 CORPORATE DR. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Street | 325 CORPORATE DR. |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASSPORT A/R FEM. ALIGN. GUIDE |
| Generic Name | INSTRUMENT |
| Product Code | LXI |
| Date Received | 2010-05-24 |
| Model Number | NA |
| Catalog Number | 7650-5901 |
| Lot Number | RD4N219 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS MAHWAH |
| Manufacturer Address | MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-05-24 |