MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-04-30 for CASTROVIEJO-MICRO NEEDLEHOLDERS STRAIGHT, MICRO INSERT N/A 51-6650 manufactured by Biomet Microfixation.
[106976468]
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[106976469]
It was reported the tip of the instrument fractured. There was no delay or injury and the fractured piece was recovered. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00221 |
| MDR Report Key | 7473492 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-04-30 |
| Date of Report | 2018-08-21 |
| Date Mfgr Received | 2018-07-26 |
| Device Manufacturer Date | 2006-06-02 |
| Date Added to Maude | 2018-04-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASTROVIEJO-MICRO NEEDLEHOLDERS STRAIGHT, MICRO INSERT |
| Generic Name | NEEDLE HOLDER |
| Product Code | HXK |
| Date Received | 2018-04-30 |
| Returned To Mfg | 2018-04-25 |
| Model Number | N/A |
| Catalog Number | 51-6650 |
| Lot Number | 060526E06 |
| ID Number | (01)00841036049171 |
| Operator | DENTIST |
| 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 | 2018-04-30 |