MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-03 for OMNI-FLEX STERILE FIELD POST 10244 manufactured by Integra Lifesciences Corporation Oh/usa.
[69104127]
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
[69104128]
Customer initially reports the omni post 10244 has defective internal clamp components which wear out prematurely over a two to four month time period. This causes the entire omni system to slip and rotate during surgery. The retractor blades begin to move during the operation. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
[73715340]
On 3/29/27 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis - evaluation verified customer information as valid. Device failed dimensional and functional checks. Device shows normal wear and tear on outside, but when disassembles excessive wear is obvious. Cam is visually bent and there are wear marks on. 500 dia indicating over use. Cam body has visual wear marks from excess handle throw. Peek cam bolt bushing. 390 internal diameter is visually worn on throw side. Device history evaluation - device history record reviewed for this product id a total of 40 manufactured in 2015 show no abnormalities related to the reported failure. The devices manufactured during this period passed all required inspection points with no associated mrr? S, variances or rework. Conclusion: in summary the end users reason for return was verified the most probable cause could be use error. Please note that a capa has been issued to further investigate this reported failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125289-2017-00003 |
| MDR Report Key | 6378003 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-03 |
| Date of Report | 2017-02-10 |
| Date of Event | 2017-02-06 |
| Date Mfgr Received | 2017-03-29 |
| Device Manufacturer Date | 2015-05-04 |
| Date Added to Maude | 2017-03-03 |
| 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 LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNI-FLEX STERILE FIELD POST |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2017-03-03 |
| Returned To Mfg | 2017-02-17 |
| Catalog Number | 10244 |
| Lot Number | 154 |
| 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 LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-03 |