MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-26 for PERIOTOME HATCHET DE 70-171 manufactured by Integra York, Pa Inc..
[25115363]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[25115364]
Customer initially reports the tip broke off while using - no injury occurred. (b)(6) 2015, customer reports the doctor was performing a tooth extraction. The doctor was inserting tip between the tooth & periodontal ligament and it broke off in the patients mouth, used gauze to remove it. Per doctor, used preventative measures, gauze, so patient did not swallow tip.
Patient Sequence No: 1, Text Type: D, B5
[34208355]
On 9/15/2015 integra investigation completed. Method: failure analysis, device history evaluation. Result: failure analysis: periotome hatchet in used condition, not showing any unusual markings. One tip broken off. This could have resulted in improper usage damage from applying too much pressure causing the tip to break off. 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 complaint report has been confirmed, the root cause has not been identified as a workmanship material deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00070 |
| MDR Report Key | 5031509 |
| Date Received | 2015-08-26 |
| Date of Report | 2015-07-29 |
| Date of Event | 2015-07-26 |
| Report Date | 2015-07-29 |
| Date Reported to Mfgr | 2015-07-29 |
| Date Mfgr Received | 2015-09-15 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2015-08-26 |
| 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 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 HATCHET DE |
| Generic Name | M54 - ORAL SURGERY |
| Product Code | EIF |
| Date Received | 2015-08-26 |
| Returned To Mfg | 2015-07-30 |
| Catalog Number | 70-171 |
| 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 PA 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-26 |