MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-05-15 for HOLDER, NEEDLE; ORTHOPEDIC N/A 51-6502 manufactured by Biomet Microfixation.
[75215681]
"ah" is etched on the instrument, indicating the instrument was manufactured between january through june in 1992. 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.
Patient Sequence No: 1, Text Type: N, H10
[75215682]
It was reported that half of the insert fell out of the instrument. The incident did not occur during a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00389 |
| MDR Report Key | 6567366 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-15 |
| Date of Report | 2017-05-15 |
| Date Mfgr Received | 2017-07-20 |
| Date Added to Maude | 2017-05-15 |
| 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 | HOLDER, NEEDLE; ORTHOPEDIC |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT, HALSEY NEEDLEHOLDER FINE TC |
| Product Code | HXK |
| Date Received | 2017-05-15 |
| Returned To Mfg | 2017-04-21 |
| Model Number | N/A |
| Catalog Number | 51-6502 |
| Lot Number | UNKNOWN |
| 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 | 2017-05-15 |