MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for BOX CHISEL 6541-4-709 manufactured by Stryker Orthopaedics-mahwah.
[142910178]
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other events for the lot referenced. It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[142910179]
Primary procedure, left knee. It was reported that during impaction, part of the box chisel broke off and fell into the patient. All pieces were removed and patient was irrigated. The procedure was completed successfully with no delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002249697-2019-01693 |
| MDR Report Key | 8541907 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-03-26 |
| Date Mfgr Received | 2019-07-02 |
| Device Manufacturer Date | 2006-06-17 |
| Date Added to Maude | 2019-04-23 |
| 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. COLLIN NEITZEL |
| 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 | 0 |
| Brand Name | BOX CHISEL |
| Generic Name | CHISEL, SURGICAL, MANUAL |
| Product Code | FZO |
| Date Received | 2019-04-23 |
| Returned To Mfg | 2019-04-18 |
| Catalog Number | 6541-4-709 |
| Lot Number | PZS50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-23 |