MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-13 for FOMON RASP TC 8.25 DE 5/6 COARSE/COARSE BACKWARD 21-382TC manufactured by Integra York, Pa Inc..
[57797821]
Integra has completed their internal investigation on september 15, 2016. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaints history. Results: evaluation of returned device; the returned fomon rasp tc showing staining/pitting within grooves was tested with plastic round profile. Inserts grasped material as intended. There was no signs of the insert sliding off of material. Dhr review; no nonconforming product report / nonconforming material report history. No corrective action preventive action history/corrections. No health hazard evaluation history. Complaints history; complaints metrics tracked, trended, and reviewed monthly with management. Conclusion: the complaint is unconfirmed; testing within specification.
Patient Sequence No: 1, Text Type: N, H10
[57797822]
It was reported that both grasps edges fail to grasp septum bone firmly. According to customer, is not meeting quality standards. Device was in contact with the patient however, no patient injury reported and the event lead to surgical delay, unknown for how long.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2016-00176 |
| MDR Report Key | 6028411 |
| Date Received | 2016-10-13 |
| Date of Report | 2016-08-26 |
| Date Mfgr Received | 2016-09-15 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2016-10-13 |
| 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 | 0 |
| Brand Name | FOMON RASP TC 8.25 DE 5/6 COARSE/COARSE BACKWARD |
| Generic Name | M12 - PLASTIC SURGERY |
| Product Code | GAC |
| Date Received | 2016-10-13 |
| Returned To Mfg | 2016-09-14 |
| Catalog Number | 21-382TC |
| Lot Number | 100194-1507 |
| 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 | 2016-10-13 |