MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-12-10 for CUTTING EDGE ADV RASP HANDLE 1100-1000 manufactured by Stryker Orthopaedics Mahwah.
[21284741]
It was reported that: "upon inspection of the tray, found handles were cracked by two small through holes on handle body. "
Patient Sequence No: 1, Text Type: D, B5
[21480128]
Summary of eval: the investigation concluded that the event is related to other previous events for this product where the handle fractured inferior to the strike plate. Investigations of these previous events concluded that the root cause was design related. Design change was released to strengthen the area between the strike plate and handle. The per devices were mfg to the previous design configuration.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2249697-2010-01711 |
| MDR Report Key | 1946381 |
| Report Source | 07 |
| Date Received | 2010-12-10 |
| Date of Report | 2010-11-15 |
| Date of Event | 2010-11-15 |
| Date Mfgr Received | 2010-11-15 |
| Date Added to Maude | 2011-10-06 |
| 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 | MRUNALI PATEL |
| 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 | RA2009-050 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUTTING EDGE ADV RASP HANDLE |
| Generic Name | INSTRUMENT |
| Product Code | EKA |
| Date Received | 2010-12-10 |
| Model Number | NA |
| Catalog Number | 1100-1000 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2010-12-10 |