MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-06 for HOUSE CURETTE 7-1/8 STRONG-ANG 385401 manufactured by Integra York, Pa Inc..
[76951854]
On 5/25/17 integra investigation completed. Method: failure analysis, device history evaluation results; failure analysis - failure analysis cannot be performed based on the lack of information provided by the customer. The curette was not returned for further evaluation. Device history evaluation - dhr review: nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: none. Corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion - root cause cannot be determined due to the lack of information received to perform a complete investigation. The curette was not returned for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
[76951855]
Fda medwatch # mw5069354 reports that while utilizing a curette to remove fibrous tissue and cortical bone from the non-union site, the tip of the curette broke off in the middle of the phalanx. On (b)(6) 2017 no further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00063 |
| MDR Report Key | 6616019 |
| Date Received | 2017-06-06 |
| Date of Report | 2017-05-09 |
| Date Mfgr Received | 2017-05-09 |
| Date Added to Maude | 2017-06-06 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HOUSE CURETTE 7-1/8 STRONG-ANG |
| Generic Name | N/A |
| Product Code | FZS |
| Date Received | 2017-06-06 |
| Catalog Number | 385401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-06 |