MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-12-04 for MANUAL ORTHOPEDIC SURGICAL INSTRUMENT 9560631 manufactured by Medtronic Sofamor Danek.
[1456610]
It was reported that the tip of the instrument was broken off during use, but immediately was retrieved. Although the instrument was used in surgery, no patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[8302322]
(b) (4): device was returned to the manufacturer for evaluation. The visual examination shows that curette tip is broken; approximately 3mm of tip missing and not returned for analysis. Microscopic examination of fracture revealed a fairly tortuous, ductile fracture surface and no indications of fatigue were visible, suggesting failure due to bending stresses. The above observations are consistent with misuse due to bend stress overloading, resulting in the foregoing failure. Device history records were reviewed. No documentation was found that would indicate a non-conformance to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2009-01140 |
| MDR Report Key | 1556406 |
| Report Source | 07 |
| Date Received | 2009-12-04 |
| Date of Report | 2009-11-05 |
| Date of Event | 2009-11-05 |
| Date Mfgr Received | 2009-11-05 |
| Device Manufacturer Date | 2006-12-19 |
| Date Added to Maude | 2010-03-25 |
| 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 |
| Manufacturer Street | 7375 ADRIANNE PLACE |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38133 |
| 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 | HTF |
| Date Received | 2009-12-04 |
| Returned To Mfg | 2009-11-18 |
| Model Number | NA |
| Catalog Number | 9560631 |
| Lot Number | GZ06L017 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Address | 7375 ADRIANNE PLACE BARTETT TN 38133 US 38133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-04 |