MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2016-03-28 for OCHSNER FCPS 61/4 STR SATIN 106200 manufactured by Integra York, Pa Inc..
[41261544]
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
[41261605]
Dealer initially reports this instrument was broken from the boxlock, rusted and twisted from the tip during orthopedic surgery. No broken parts inside the patient. Update 3/15/16 dealer reports x-ray confirms no parts in patient.
Patient Sequence No: 1, Text Type: D, B5
[45252296]
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: variance authorization / deviation history: there is no applicable variance authorization / deviation history: 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
[62550039]
On 11/08/2016 integra investigation completed. Date of manufacture: 12/2013 and 05/2014. Method: failure analysis, device history evaluation. Results: failure analysis - two forceps returned in used condition, not showing any unusual markings. The returned forceps showing wear, staining/discoloration, cracking and a slightly bent tip. Upon visually inspecting the instruments, it is noticed that the hinge has excessive staining and discoloration. There is also cracking/breakage on one out of the two hinges. One of the tips are slightly bent. The complaint is confirmed. Device history evaluation - dhr review: nonconforming product report / nonconforming material report history: variance authorization / deviation history: there is no applicable variance authorization / deviation history: 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 | 2523190-2016-00042 |
| MDR Report Key | 5528730 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2016-03-28 |
| Date of Report | 2016-03-09 |
| Date Mfgr Received | 2016-11-08 |
| Date Added to Maude | 2016-03-28 |
| 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 61/4 STR SATIN |
| Generic Name | N/A |
| Product Code | HRQ |
| Date Received | 2016-03-28 |
| Returned To Mfg | 2016-10-28 |
| Catalog Number | 106200 |
| 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 | 2016-03-28 |