MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-02-25 for 3D CROWN MAYFIELD SLIDER ASSY 292301030 manufactured by Depuy Synthes Spine.
[4285108]
International affiliate reports the connector part of the 3d crown mayfield slider assembly and the halo adaptor set for mayfield had been broken and the devices could not be assembled to each other when the surgeon tried to use them at the beginning of the surgery. The surgery was planned to be processed with a halo vest for the patient who had cervical fracture. However, the products could not be used and the surgeon completed the cervical internal fixation surgery without the halo vest. See mfg medwatch report no 1526439-2014-11309 for the halo adaptor set for mayfield that was involved in the event.
Patient Sequence No: 1, Text Type: D, B5
[11622456]
A follow up report will be filed upon completion of the investigation. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[26787431]
Visual inspection of the 3d slider adapter revealed that the 1/4-28 unf? 2b hole showed signs of peeled threads and thread deformation at the entry point which is consistent with cross-threading. A review of the device history record for the 3d slider adapter no discrepancies during the manufacturing of the product. No issues were identified during the manufacturing and release of this product that could have been contributed to the problem reported by the customer. The product was released accompanying all quality requirements. A 12 month review of the complaint trend analysis for the 3d slider adapter and mayfield adapter set was conducted on the specific codes from the complaint as a device family does not exist for these instruments. It was noted that there were no related complaints for the inability to assemble the 3d slider adapter to the mayfield adapter or vice versa. The results of this trending suggest that this is an isolated event. Review of complaints found no significant trends. The root cause is unknown however it is likely that as the 3d slider adapter was being attached to the mayfield adapter, the connection became cross threaded resulting in the inability for these components to be fully assembled. No corrective action/preventive action is required as there has been no issue identified in the manufacturing or release of this device, and there have been no systematic trends. Therefore, this complaint will be closed with no further action required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2014-11308 |
| MDR Report Key | 3645397 |
| Report Source | 01,05,07 |
| Date Received | 2014-02-25 |
| Date of Report | 2014-01-30 |
| Date of Event | 2014-01-30 |
| Date Mfgr Received | 2014-04-03 |
| Device Manufacturer Date | 2013-05-07 |
| Date Added to Maude | 2014-02-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | ANITA BARNICK |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283583 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3D CROWN MAYFIELD SLIDER ASSY |
| Generic Name | COMPONENT, TRACTION, INVASIVE |
| Product Code | JEC |
| Date Received | 2014-02-25 |
| Returned To Mfg | 2014-03-24 |
| Catalog Number | 292301030 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-25 |