MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for RETRACTOR manufactured by .
[180035348]
During operative procedure, one (1) of two (2) hohmann retractors in use by the surgeon "broke off in the acetabulum," leaving approximately 8mm of a retractor tip imbedded in the joint capsule. Intraoperative x-ray was refused by the surgeon; he deemed the retractor tip "not retrievable. " surgical site was closed and patient discharged to pacu under care of anesthesia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9727580 |
| MDR Report Key | 9727580 |
| Date Received | 2020-02-19 |
| Date of Report | 2019-12-31 |
| Date of Event | 2019-12-16 |
| Report Date | 2019-12-31 |
| Date Reported to FDA | 2019-12-31 |
| Date Reported to Mfgr | 2020-02-19 |
| Date Added to Maude | 2020-02-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Generic Name | RETRACTOR |
| Product Code | GAD |
| Date Received | 2020-02-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-19 |