MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-17 for BABY-CRILE-WOOD NEEDLE HOLDER FN 15CM TC N/A 51-6506 manufactured by Biomet Microfixation.
[83036444]
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.
Patient Sequence No: 1, Text Type: N, H10
[83036445]
It was reported the instrument fractured while the surgeon was opening and closing the instrument. The fracture did not occur during use on a patient and the instrument was not over the surgical site. There was no impact to the patient or procedure as another instrument was available and used in the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00674 |
| MDR Report Key | 6802275 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-17 |
| Date of Report | 2018-01-31 |
| Date Mfgr Received | 2018-01-30 |
| Device Manufacturer Date | 2013-10-14 |
| Date Added to Maude | 2017-08-17 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BABY-CRILE-WOOD NEEDLE HOLDER FN 15CM TC |
| Generic Name | HOLDER, NEEDLE;ORTHOPEDIC |
| Product Code | HXK |
| Date Received | 2017-08-17 |
| Returned To Mfg | 2017-08-14 |
| Model Number | N/A |
| Catalog Number | 51-6506 |
| Lot Number | 101413J13 |
| 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 | 2017-08-17 |