MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-04-06 for OCHSNER FCPS 8 STR SATIN 106220 manufactured by Integra York, Pa Inc..
[42033157]
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
[42033158]
Dealer initially reports the instrument was broken during orthopedic surgery in direct contact with patient under normal conditions and there are no broken parts inside the patient. On 3/25/2016 dealer not responding. No further information available.
Patient Sequence No: 1, Text Type: D, B5
[45242305]
On 5/10/16 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - failure analysis cannot be completed due to the lack of information received to perform a complete investigation. Unconfirmed. No return of device for evaluation. Device history evaluation - dhr review: nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: none. Corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[62549694]
On 11/08/2016 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - forceps returned in used condition, not showing any unusual markings, showing wear, discoloration/staining within the finish and a tip is broken. Without knowing how the forcep was handled and maintained, the cause is undetermined. The complaint is confirmed. Device history evaluation - dhr review nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: none. 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 | 2523190-2016-00055 |
| MDR Report Key | 5552031 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-04-06 |
| Date of Report | 2016-03-09 |
| Date Mfgr Received | 2016-11-08 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2016-04-06 |
| 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 | OCHSNER FCPS 8 STR SATIN |
| Generic Name | N/A |
| Product Code | HRQ |
| Date Received | 2016-04-06 |
| Returned To Mfg | 2016-10-28 |
| Catalog Number | 106220 |
| Lot Number | 8859113 |
| 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 | 2016-04-06 |