MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-06-25 for SPOTLIGHT 4MM DOWN BITE CURETTE 292903404 manufactured by Depuy Synthes Spine.
[4647046]
It was reported that the spotlight curette broke when being used during an open lami/discectomy procedure. The sales representative was not present during the case and is unable to provide any additional information regarding the event. As it is possible that the distal tip portion of the curette broke during usage, this medwatch report is being filed to document the event.
Patient Sequence No: 1, Text Type: D, B5
[12110183]
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
[26793196]
The spotlight 4mm down biting curette was not returned for evaluation. Review of the device history record found no discrepancies. The product was released accomplishing all quality requirements. A 12-month review of the complaint trend analysis on the product family found no emerging trends. Without the return of the 4mm down biting curette we are unable to confirm the reported issue or identify the root cause. No corrective action/preventive action is necessary at this time as we are unable to confirm the reported issue or identify the root cause. No systemic trend has been observed. Therefore, this complaint file will be closed with no further action required. If the sample of concern from this complaint file becomes available, the complaint file will be re-opened and the product evaluated. 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
| Report Number | 1526439-2014-11630 |
| MDR Report Key | 3894524 |
| Report Source | 05,07 |
| Date Received | 2014-06-25 |
| Date of Report | 2014-06-02 |
| Date of Event | 2014-06-02 |
| Date Mfgr Received | 2014-07-31 |
| Device Manufacturer Date | 2012-03-09 |
| Date Added to Maude | 2014-07-16 |
| 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 | 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 | SPOTLIGHT 4MM DOWN BITE CURETTE |
| Generic Name | CURETTE |
| Product Code | HTF |
| Date Received | 2014-06-25 |
| Returned To Mfg | 2014-06-06 |
| Catalog Number | 292903404 |
| Lot Number | HG1044283 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-06-25 |