MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-01-12 for HLS KNEETEC MDI129 NOT APPLICABLE manufactured by Corin Medical.
[97053828]
B)(4) initial report. Additional information, including a detailed patient outcome has been requested in order to progress with the investigation. The surgeon has planned to review the patient before end of (b)(4) and has also stated that he will reported the incident to ansm the appropriate device details are described below: the first informations are that the batch is (b)(4) parts one manufactured in december 2009: no non conformity were detected on this batch. The raw material is not implantable , and surgeon was informed on 28 dec 2017. Please note: this report is filed with fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
Patient Sequence No: 1, Text Type: N, H10
[97053829]
A drill broke without possibility of extraction during a knee surgery. One piece was left in the patient's bone. The drill is an hls kneetec im drill mdi129 lot 09e389.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614209-2018-00003 |
| MDR Report Key | 7185187 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-01-12 |
| Date of Report | 2018-01-12 |
| Date of Event | 2017-12-14 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2018-01-12 |
| 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 | MR. FRANCK DIDIER |
| Manufacturer Street | THE CORINIUM CENTRE |
| Manufacturer City | CIRENCESTER, GLOUCESTERSHIRE GL71YJ, |
| Manufacturer Country | UK |
| Manufacturer Postal | GL7 1YJ, |
| Manufacturer G1 | CORIN MEDICAL |
| Manufacturer Street | THE CORINIUM CENTRE |
| Manufacturer City | CIRENCESTER, GLOUCESTERSHIRE GL7 YJ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | GL7 YJ |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HLS KNEETEC |
| Generic Name | INTRA MEDULLAR DRILL |
| Product Code | KRR |
| Date Received | 2018-01-12 |
| Returned To Mfg | 2017-12-21 |
| Model Number | MDI129 |
| Catalog Number | NOT APPLICABLE |
| Lot Number | 09E389 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORIN MEDICAL |
| Manufacturer Address | THE CORINIUM CENTRE CIRENCESTER, GLOUCESTERSHIRE GL71YJ, UK GL7 1YJ, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-12 |