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 2017-03-10 for MAYO-HEGAR NEEDLE HOLDER STANDARD TC N/A 51-6511 manufactured by Biomet Microfixation.
[69651648]
Ak is the date code etched on the product which identifies the item as being manufactured between january and june of 1995, however the lot number is unable to determined. A visual inspection revealed moderate signs of wear including minor scratches and spots of discoloration. A small piece of the knurled jaw was broken off. The most-likely cause for the complaint was determined to be excessive force. There are no indications of manufacturing defects. This report is late as it was part of a retrospective review based on enhancements made to our reporting policies.
Patient Sequence No: 1, Text Type: N, H10
[69651649]
It was originally reported this instrument "doesn't latch anymore. " the event occurred during surgery with no delay or harm to the patient. However the product evaluation identified the product was broken at the tip. See h10 narrative for the product evaluation details.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00145 |
| MDR Report Key | 6396979 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-10 |
| Date of Report | 2016-12-09 |
| Date Mfgr Received | 2016-12-09 |
| Date Added to Maude | 2017-03-10 |
| 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 |
| 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 | MAYO-HEGAR NEEDLE HOLDER STANDARD TC |
| Generic Name | NEEDLE HOLDER |
| Product Code | HXK |
| Date Received | 2017-03-10 |
| Returned To Mfg | 2016-10-28 |
| Model Number | N/A |
| Catalog Number | 51-6511 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-03-10 |