MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-10-14 for WYNMAN CARB CROWN GRIPPER 72-10TC manufactured by Integra York, Pa Inc..
[57462297]
On 9/28/16 integra investigation completed. Manufacture date unknown. Method: failure analysis, device history evaluation. Results: failure analysis - a gripper in used condition, not showing any unusual markings, showing wear, staining and discoloration, battered finish, and broken insert. During the visual inspection of the instrument, it is noticed that the finish is worn and there is staining/discoloration. It is also noticed that the insert is broken on one of the tips. The damage to the insert appears to have started as a hairline fractured, leading to the breakage. 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
[57462298]
Customer initially reports the insert broke while using. On (b)(6) 2016 doctor reports he was gripping a crown when a tip of the carbide insert broke off in the mouth and was retrieved. No harm done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2016-00164 |
| MDR Report Key | 6029644 |
| Report Source | USER FACILITY |
| Date Received | 2016-10-14 |
| Date of Report | 2016-09-15 |
| Date Mfgr Received | 2016-09-15 |
| Date Added to Maude | 2016-10-14 |
| 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 |
| Reporter Occupation | MEDICAL ASSISTANT |
| 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 | WYNMAN CARB CROWN GRIPPER |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | EIS |
| Date Received | 2016-10-14 |
| Returned To Mfg | 2016-09-26 |
| 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 | 2016-10-14 |