MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-19 for HOLMAN RETRACTOR 225-440 manufactured by Integra Lifesciences Corporation.
[57813598]
Patient Sequence No: 1, Text Type: N, H10
[57813599]
During a surgical procedures for bilateral ex-fixation of upper extremities, the left arm was completed. During the procedure to the right arm, the surgeon was using a holman retractor on the humerus when he felt a pop. The tip of the holman had broken off and became retained under the patient's right upper arm. The surgeon was unable to remove the tip of the retractor and decided to leave it in due to the potential risk of injury to the radial nerve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6039517 |
| MDR Report Key | 6039517 |
| Date Received | 2016-10-19 |
| Date of Report | 2016-09-26 |
| Date of Event | 2016-05-08 |
| Report Date | 2016-05-17 |
| Date Reported to FDA | 2016-05-17 |
| Date Reported to Mfgr | 2016-05-17 |
| Date Added to Maude | 2016-10-19 |
| 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 | HOLMAN RETRACTOR |
| Generic Name | RETRACTOR |
| Product Code | GZT |
| Date Received | 2016-10-19 |
| Model Number | 225-440 |
| Catalog Number | 225-440 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 4900 CHARLEMAR DR., BUILDING A CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-19 |