MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-14 for WYNMAN CARB CROWN GRIPPER 72-10TC manufactured by Integra York, Pa Inc..
[55041133]
On 8/31/2016 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - a gripper was returned in used condition, showing wear, staining and damaged inserts. While doing the visual inspection of the instrument, it is noticed that there is staining and discoloration at the insert area. It is also noticed that the inserts are slightly worn. Without knowing how the instrument was handled or maintained during autoclaving, the cause is undetermined. The complaint report is confirmed. Device history 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/corrections: none. Health hazard evaluation history: none. Conclusion: the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[55041134]
Customer initially reports inserts "dissolved" or disappeared after sterilizing, it was used and it damaged a crown. On 9/1/2016 no further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2016-00139 |
| MDR Report Key | 5948938 |
| Date Received | 2016-09-14 |
| Date of Report | 2016-08-22 |
| Date Mfgr Received | 2016-08-22 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2016-09-14 |
| 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 | WYNMAN CARB CROWN GRIPPER |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | EIS |
| Date Received | 2016-09-14 |
| Returned To Mfg | 2016-08-31 |
| Catalog Number | 72-10TC |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-09-14 |