MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-10 for TROCAR HANDLE N/A WILLIA manufactured by Biomet Microfixation.
[75003402]
Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. Device product code: kte.
Patient Sequence No: 1, Text Type: N, H10
[75003403]
It was reported the trocar handle has a lever that is stuck. The lever that switches the trocar from drill to screw was lodged and even after soaking in milk was still unable to switch the lever. There was no surgery or patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00387 |
| MDR Report Key | 6556981 |
| Date Received | 2017-05-10 |
| Date of Report | 2017-05-10 |
| Date of Event | 2017-04-13 |
| Date Mfgr Received | 2017-04-14 |
| Date Added to Maude | 2017-05-10 |
| 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 | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TROCAR HANDLE |
| Generic Name | EAR, NOSE, AND THROAT MANUAL SURGICAL INSTRUMENT |
| Product Code | KTE |
| Date Received | 2017-05-10 |
| Model Number | N/A |
| Catalog Number | WILLIA |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-10 |