MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-10-14 for ION NITRIDED CAST CUTTER BLADE 0840023000 manufactured by Stryker Instruments Cork.
[1837111]
It was reported that while removing a cast using the cast cutter with a ion nitrided cast cutter blade, the patient received a laceration on the thumb and required stitches. Additional information surrounding the event has been requested from the account.
Patient Sequence No: 1, Text Type: D, B5
[8688537]
The cast cutter and blade were returned to the manufacturer for evaluation. A cut test found that the blade was loose. The collar had markings indicating that it was seated incorrectly. If the retaining ring is not seated correctly, it is possible that the screw could back up, causing the blade to become loose. Additional information on the details surrounding this event has been requested from the account. This report will be updated when additional information is provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616696-2010-00303 |
| MDR Report Key | 1873031 |
| Report Source | 06 |
| Date Received | 2010-10-14 |
| Date of Report | 2010-09-17 |
| Date of Event | 2010-08-16 |
| Date Mfgr Received | 2010-09-17 |
| Date Added to Maude | 2010-10-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS CORK |
| Manufacturer Street | CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK |
| Manufacturer City | CARRIGTWOHILL, CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ION NITRIDED CAST CUTTER BLADE |
| Generic Name | CAST REMOVAL INSTRUMENT |
| Product Code | LGG |
| Date Received | 2010-10-14 |
| Returned To Mfg | 2010-09-17 |
| Catalog Number | 0840023000 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS CORK |
| Manufacturer Address | CARRIGTWOHILL, CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-10-14 |