MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,company representati report with the FDA on 2013-07-15 for MANUAL ORTHOPEDIC SURGICAL INSTRUMENT 873-004 manufactured by Medtronic Sofamor Danek Usa, Inc.
[3570794]
It was reported that the patient underwent a cervical spinal surgery to treat a retroodontoid pseudotumor. It was reported that during insertion of the guidewire through the guide and a trocar using a power tool, the guidewire fractured in the bone before it perforated c2 arthrosis. The tip was lodged in the c2 bone. A diamond bur was used to widen the insertion point to reach the fragment. After the fragment was drilled, the surgeon was able to remove the fragment using pliers. The surgery was continued using a new guidewire without any further incidents. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[10900023]
(b)(4): the device has been returned to the manufacturer for evaluation. Analysis results are not available at the time of this report. A follow-up report will be sent when the analysis is complete.
Patient Sequence No: 1, Text Type: N, H10
[23841078]
Visual review identified bend in approximately the middle of the guidewire, with approximately ~35mm of the proximal tip broken off and not returned for analysis. Optical inspection of the shaft identified axial galling in multiple locations near the proximal tip and adjacent to the fracture surface, consistent with off-axis trajectory while under power. Dimensional inspection confirms shaft diameter conforms to print specification. Review of lhr documentation confirms conformance to chemical composition per msd-ms-119 type f. The above observations are consistent with off-axis trajectory of the instrument while under power, resulting in axial galling of the shaft until failure of the instrument.
Patient Sequence No: 1, Text Type: N, H10
[100084862]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2013-03017 |
| MDR Report Key | 3226116 |
| Report Source | 01,05,07,COMPANY REPRESENTATI |
| Date Received | 2013-07-15 |
| Date of Report | 2013-06-16 |
| Date of Event | 2013-06-16 |
| Date Mfgr Received | 2013-08-21 |
| Device Manufacturer Date | 2013-04-19 |
| Date Added to Maude | 2013-07-15 |
| 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 | HUZEFA MAMOOLA |
| 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 | 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 | CHAIR, SURGICAL, NON-ELECTRICAL |
| Product Code | FZK |
| Date Received | 2013-07-15 |
| Returned To Mfg | 2013-06-20 |
| Model Number | NA |
| Catalog Number | 873-004 |
| Lot Number | SW12M145 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-15 |