MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-01-13 for BOX CHISEL 6541-4-709 manufactured by Stryker Orthopaedics-mahwah.
[187911682]
An event regarding an intraoperative fracture involving a triathlon chisel was reported. The event was not confirmed. Method & results: device evaluation and results: not performed as product was not returned. Clinician review: no medical records were received for review with a clinical consultant. Device history review: could not be performed as lot code information was not provided. Complaint history review: could not be performed as lot code information was not provided. Conclusion: the exact cause of the event could not be determined because insufficient information was provided. Additional information including operative reports and return of the device are needed to fully investigate the event. If further information becomes available or the product is returned, this investigation will be re-opened. Not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[187911683]
Primary procedure, left knee. It was reported that after using the ps box guide and chisel, a crack in the patient's medial condyle was noted. The fracture was addressed using a k-wire, and the surgery was completed with no delay. The rep reported that the devices will be kept in use by the hospital, and that no further information will be released by the hospital or surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2020-00075 |
| MDR Report Key | 9584506 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-13 |
| 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 | 3 |
| Manufacturer Contact | MR. JOANN LAVATELLI |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOX CHISEL |
| Generic Name | CHISEL, SURGICAL, MANUAL |
| Product Code | FZO |
| Date Received | 2020-01-13 |
| Catalog Number | 6541-4-709 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOPAEDICS-MAHWAH |
| Manufacturer Address | 325 CORPORATE DRIVE MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-13 |