MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-01-15 for MANUAL ORTHOPEDIC SURGICAL INSTRUMENT EX1009433 manufactured by Medtronic Sofamor Danek Usa, Inc..
[20936410]
It was reported that the tip of the custom curette broke off during surgery. The tip broke off in the patient. All the pieces were found and removed from the patient and the sterile field. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[21198462]
(b) (4). The curette was not returned for evaluation. With the available information a cause or contributing factor cannot be identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2010-00062 |
| MDR Report Key | 1587990 |
| Report Source | 05,07 |
| Date Received | 2010-01-15 |
| Date of Report | 2009-12-17 |
| Date of Event | 2009-12-17 |
| Date Mfgr Received | 2009-12-17 |
| Date Added to Maude | 2010-06-03 |
| 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 | CHAD ASHTON |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC. |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT |
| Generic Name | CURETTE |
| Product Code | FZS |
| Date Received | 2010-01-15 |
| Model Number | NA |
| Catalog Number | EX1009433 |
| Lot Number | H09L017 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC. |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-15 |