MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-01 for PERIOTOME STRAIGHT DE 70-170 manufactured by Integra York, Pa Inc..
[49395212]
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
[49395213]
Customer initially reports tip broke off. On (b)(6) 2016 dealer report states device broke during first use on an extraction. Broken piece was removed, no harm done.
Patient Sequence No: 1, Text Type: D, B5
[49516439]
On 07/05/2016 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis - periotome returned in used condition, not showing any unusual markings. The periotome shows wear and a broken tip. Without knowing how much pressure was used during the extraction, excess force applied to the tip of the instrument may have led to the tip breaking. This type of damage is typically the result of improper usage. The complaint 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: 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
| Report Number | 2523190-2016-00099 |
| MDR Report Key | 5764952 |
| Date Received | 2016-07-01 |
| Date of Report | 2016-06-13 |
| Date of Event | 2016-06-10 |
| Date Mfgr Received | 2016-07-05 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2016-07-01 |
| 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 | PERIOTOME STRAIGHT DE |
| Generic Name | M54 - ORAL SURGERY |
| Product Code | EKC |
| Date Received | 2016-07-01 |
| Returned To Mfg | 2016-06-28 |
| Catalog Number | 70-170 |
| 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 | 2016-07-01 |