MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-08 for TROCAR HANDLE N/A 46-0012 manufactured by Biomet Microfixation.
[54267196]
Device product code is kte (not available on drop down list). Without a product return, no product evaluation is able to be conducted. 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.
Patient Sequence No: 1, Text Type: N, H10
[54267197]
The sales associate reported there was a problem with the trocar. A percutaneous incision was made; the trocar and cheek retractor were placed in the patient, the drill sleeve was placed into the hand piece/cheek retractor and became lodged. Approximately 30 minutes later, it was realized that the drill guide (sleeve) had dropped into the cheek retractor and the trocar handle, and by using covers, forceps, they were able to disassemble and use a kohker to remove the initial instrument. The available second trauma one set was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[61416688]
Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[62726779]
All three parts (trocar handle, cheek retractor, and drill guide) were returned assembled together. The cheek retractor was clamped into the trocar handle and the drill guide was inserted into the trocar handle. There appears to be no damage on the trocar handle after a visual inspection. All three parts were easily disassembled. A visual inspection of the cheek retractor shows that there are scratches and some material deformation where the retractor interfaces with the trocar handle. The drill guide has some scratches on the surface that is pressed up against the trocar handle. Where the drill is inserted into the drill guide, there is wear in a circular pattern that appears to be from the rotation handle that the drill is attached to. The three parts were assembled and disassembled multiple times to try to replicate the complaint. Each time the parts were easily assembled and disassembled; therefore the complaint is not confirmed. The most likely underlying cause of this complaint cannot be determined as the parts functioned as intended. The inspection history was reviewed and no non-conformances were identified. There are no indications of manufacturing defects.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2016-00500 |
| MDR Report Key | 5938123 |
| Date Received | 2016-09-08 |
| Date of Report | 2016-08-12 |
| Date of Event | 2016-08-11 |
| Date Mfgr Received | 2016-12-08 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2016-09-08 |
| 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 | 3 |
| Brand Name | TROCAR HANDLE |
| Generic Name | HANDLE |
| Product Code | KTE |
| Date Received | 2016-09-08 |
| Returned To Mfg | 2016-12-01 |
| Model Number | N/A |
| Catalog Number | 46-0012 |
| Lot Number | 329695 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2016-09-08 |