MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-15 for UNKNOWN 6118-27-20 manufactured by Stryker Instruments.
[59902101]
Patient Sequence No: 1, Text Type: N, H10
[59902102]
A piece of the saw blade broke in the surgical field during a revision of a tkr. An x-ray obtained confirmed no foreign body was present. Later the trial insert was noted as broken, as a small piece of blue plastic was noted on the surgical field, another x-ray was obtained, no foreign body visualized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6102758 |
| MDR Report Key | 6102758 |
| Date Received | 2016-11-15 |
| Date of Report | 2016-09-22 |
| Date of Event | 2016-09-13 |
| Report Date | 2016-09-22 |
| Date Reported to FDA | 2016-09-22 |
| Date Reported to Mfgr | 2016-09-22 |
| Date Added to Maude | 2016-11-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | SAW, ELECTRICALLY POWERED |
| Product Code | DWI |
| Date Received | 2016-11-15 |
| Model Number | 6118-27-20 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-15 |