MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-26 for ROUND CALCAR PUNCH MEDIUM 20070053 manufactured by Microport Orthopedics Inc..
[160250930]
This event will be updated when investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[160250931]
Allegedly, universal handle: breaking of the teeth conjunction broach tip zelpi retractors: the self retaining teeth doesn't keep the position round calcars: breaking of the conjunction fillet. Surgery was extended greater than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[182636671]
Additional information received by reporter reveals that this is a non-reportable incident. No serious injury occurred in this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010536692-2019-01055 |
| MDR Report Key | 9126012 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-09-26 |
| Date of Report | 2019-09-26 |
| Date of Event | 2019-08-08 |
| Date Facility Aware | 2019-08-28 |
| Date Mfgr Received | 2019-09-26 |
| Date Added to Maude | 2019-09-26 |
| 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 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 | ROUND CALCAR PUNCH MEDIUM |
| Generic Name | HIP INSTRUMENT |
| Product Code | HWP |
| Date Received | 2019-09-26 |
| Returned To Mfg | 2019-08-28 |
| Model Number | 20070053 |
| Catalog Number | 20070053 |
| Lot Number | CN101275 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-09-26 |