MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-12-14 for FRAZIER DURA HOOK SHARP 5 26-1084 manufactured by Integra York, Pa Inc..
[33426109]
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
[33426110]
Customer initially reports device is broken. (b)(6) 2015 customer reports that device broke in use when doctor was doing procedure for skin cancer, no harm done, piece easily retrieved.
Patient Sequence No: 1, Text Type: D, B5
[38307276]
On 1/20/16 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - a frazier dura hook was returned in used condition, showing wear and scratches, no unusual markings. Evaluation of the returned hook shows the tip is broken off. Without knowing how the instrument was handled; we cannot determine what it is indicative to. 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 | 2523190-2015-00144 |
| MDR Report Key | 5294228 |
| Report Source | USER FACILITY |
| Date Received | 2015-12-14 |
| Date of Report | 2015-12-10 |
| Date of Event | 2015-12-09 |
| Date Mfgr Received | 2016-01-20 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2015-12-14 |
| 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 | 3 |
| Brand Name | FRAZIER DURA HOOK SHARP 5 |
| Generic Name | M6 - NEURO |
| Product Code | GDG |
| Date Received | 2015-12-14 |
| Returned To Mfg | 2015-12-21 |
| Catalog Number | 26-1084 |
| 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 | 2015-12-14 |