MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-05-21 for RUGGLES POPPEN INTERVERTEBRAL DISC RONGEUR - STR R1765 manufactured by Integra York, Pa Inc..
[21330154]
Customer initial reports screw fell out event desc: doctor was using a pituitary rongeur during a procedure. The tech noticed that a screw was missing from this instrument. The doctor was notified. X-ray of pt's back was done/reported as negative for screw by the doctor. Screw was then found on the floor by surgical tech. Surgeon aware. The instrument and screw were removed from the sterile field and given to materials coordinator. No harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[21817430]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
[60886783]
On 6/24/2015, integra investigation completed. Method failure analysis, device history evaluation, results: failure analysis - cannot be performed based on the lack of information provided by the customer the rongeur was not returned for further evaluation. Nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history, corrective action preventive action history: none. Health hazard evaluation history - none. Conclusion: root cause cannot be determined due to the lack of information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00028 |
| MDR Report Key | 4795266 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-05-21 |
| Date of Report | 2015-04-28 |
| Date Mfgr Received | 2015-04-28 |
| Date Added to Maude | 2015-06-19 |
| 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 | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer Country | US |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUGGLES POPPEN INTERVERTEBRAL DISC RONGEUR - STR |
| Generic Name | NA |
| Product Code | EIF |
| Date Received | 2015-05-21 |
| Catalog Number | R1765 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-21 |