MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-07 for OSTEOTOME CP313-1 GUARDED 3.0MM BECKER manufactured by Integra York, Pa Inc..
[57358668]
On 9/21/2016 integra investigation completed. Manufacture date unknown. Method: failure analysis, device history evaluation results: failure analysis - one osteotome returned in used condition, showing minimal wear, staining within the finish and broken tip. During the analysis of the instrument, it is noticed that there is slight staining within the finish and the tip is broken. Without knowing how the instrument was handled during use, the cause is undetermined. 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 of the damage has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[57358669]
Customer initially reports tip has broken off. On (b)(6) 2016 customer reports a rhinoplasty & septoplasty were being performed when the tip broke off and fell on the floor. No harm done.
Patient Sequence No: 1, Text Type: D, B5
[59595081]
10/13/16 integra investigation completed. Manufacture date unknown. Method: failure analysis, device history evaluation. Results: failure analysis - one osteotome returned in used condition showing minimal wear.. The analysis of the instrument shows that there is slight staining within the finish and the tip is broken. Without knowing how the instrument was handled during use, the cause is undetermined. The complaint report is confirmed. Device history evaluation - no nonconformity for this lot. 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 of the damage has not been identified as a workmanship or material deficiency. The cause of this damage is a fall (dropped).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00160 |
| MDR Report Key | 6011016 |
| Date Received | 2016-10-07 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-09-07 |
| Date Mfgr Received | 2016-10-13 |
| Date Added to Maude | 2016-10-07 |
| 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 | OSTEOTOME CP313-1 GUARDED 3.0MM BECKER |
| Generic Name | PFM11 |
| Product Code | GFI |
| Date Received | 2016-10-07 |
| Returned To Mfg | 2016-09-20 |
| Catalog Number | CP313-1 |
| Lot Number | 1369629 / 141002 |
| 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 | 2016-10-07 |