MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for FLEX DRILL BIT 8400-FD03 manufactured by Microport Orthopedics Inc..
[28044685]
This report will be updated when investigation is complete. Trends will be evaluated. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[28044686]
Allegedly the instrument was broken easily. Surgery time extended greater than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[31794398]
The complaint database was reviewed and analysis showed no trend for item/lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010536692-2015-01822 |
| MDR Report Key | 5132093 |
| Date Received | 2015-10-07 |
| Date of Report | 2015-10-06 |
| Date of Event | 2015-08-04 |
| Date Facility Aware | 2015-08-04 |
| Date Mfgr Received | 2015-11-16 |
| Date Added to Maude | 2015-10-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674771 |
| Manufacturer G1 | MICROPORT ORTHOPEDICS INC. |
| Manufacturer Street | 5677 AIRLINE RD. |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEX DRILL BIT |
| Generic Name | HIP INSTRUMENT |
| Product Code | LXI |
| Date Received | 2015-10-07 |
| Returned To Mfg | 2015-10-02 |
| Catalog Number | 8400-FD03 |
| Lot Number | 34147 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROPORT ORTHOPEDICS INC. |
| Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-07 |