MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-30 for BLUMENTHAL RONG 6 30DEG 22-480 manufactured by Integra York, Pa Inc..
[41766375]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[41766376]
Customer initially reports tip broke during use. (b)(6) 2016 customer reports device broke during a bone debridement of the foot. Part easily removed, no harm done.
Patient Sequence No: 1, Text Type: D, B5
[43616611]
On 3/30/16 integra investigation completed. Manufacture date unknown. Method: failure analysis, device history evaluation. Results: failure analysis - a blumenthal rongeur returned used, showing staining, discoloration, no unusual markings and a broken tip. Upon further investigation it is noticed that the tip on one of the jaws is broken off. There is discoloration at the break point which indicates the rongeur was fractured and then broke off. Not knowing how the instrument was handled/processed, the complaint report is confirmed. Device history evaluation - dhr review was completed with all history available; 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 undetermined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00029 |
| MDR Report Key | 5536530 |
| Date Received | 2016-03-30 |
| Date of Report | 2016-02-29 |
| Date of Event | 2016-02-26 |
| Date Mfgr Received | 2016-03-30 |
| Date Added to Maude | 2016-03-30 |
| 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 | 3 |
| Brand Name | BLUMENTHAL RONG 6 30DEG |
| Generic Name | M10 - ORTHOPEDIC |
| Product Code | HXI |
| Date Received | 2016-03-30 |
| Returned To Mfg | 2016-03-10 |
| Catalog Number | 22-480 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-03-30 |