MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-09-25 for NEXFIX COUNTERSINK FOR 6.5MM SCREW NCS-65CS manufactured by Tornier Inc.
[16749392]
Surgeon was using the countersink device when he felt the tip of it break. He pulled it out and could visually see that a piece of metal from the very tip had broken off. The surgeon took an xray and the small piece of the device was visible in the patient's foot. Surgeon continued with the procedure, he inserted screw he had been preparing the bone for and left the small piece of the countersink device in the patient as it was lodged in the bone.
Patient Sequence No: 1, Text Type: D, B5
[17000927]
This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004983210-2012-00013 |
| MDR Report Key | 2765801 |
| Report Source | 08 |
| Date Received | 2012-09-25 |
| Date of Report | 2012-08-28 |
| Date of Event | 2012-06-06 |
| Date Mfgr Received | 2012-08-28 |
| Date Added to Maude | 2013-01-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN SMITH |
| Manufacturer Street | 10801 NESBITT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal | 55437 |
| Manufacturer Phone | 9529217121 |
| Manufacturer G1 | TORNIER INC. |
| Manufacturer Street | 10801 NESBITT AVE SOUTH |
| Manufacturer City | BLOOMINGTON MN 55437 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEXFIX COUNTERSINK FOR 6.5MM SCREW |
| Generic Name | NONE |
| Product Code | HWW |
| Date Received | 2012-09-25 |
| Returned To Mfg | 2012-08-20 |
| Catalog Number | NCS-65CS |
| Lot Number | L8106 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER INC |
| Manufacturer Address | EDINA MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-25 |