MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-06-13 for OMNI-FLEX STERILE FIELD POST 10244 manufactured by Integra Lifesciences Corporation Oh/usa.
[47292261]
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
[47292262]
Customer reports the post is rotating/ slipping during surgery.. On (b)(6) 2016 customer reports the surgeon was performing a whipple procedure, no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
[47911789]
On 6/13/16 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - the customers? Complaint has been confirmed by engineering. However it should be noted that this field post is being returned for servicing for the first time since being replaced q1 of 2016. The serrated s. F clamp does lock onto the post clamp weld assembly but rotates on the post when a substantial amount of force is applied. Furthermore the clamp? S subassembly handle does not align parallel to the field post in both locked and unlocked positions. Although in the unlocked position force is required to cause the misalignment. There is visible wear and tear on the returned unit. Device history evaluation - device record reviewed for this product id show no abnormalities related to the reported failure. The devices manufactured passed all required inspection points with no associated mrr? S, variances or rework. Conclusion: s. F. Clamp subassembly was not functioning properly as designed. The s. F clamp subassembly primarily comprises of two. 75 serrated clamps which lock together when the handle is placed in the locked position. In the locked position, the starburst teeth do fully engage with no visible gaps present and the handle does not align parallel to the field post. In the unlocked position with the application of force on the clamp? S handle, the starburst teeth do fully engage as well and the handle remains unparalleled to the post, yet the cam body does not fully sit on the bushing between the. 75 serrated clamp and cam body as it should. Dysfunctional internal components within and on the? S. F. Clamp subassembly,. 75 x. 75 serrated? , due to user error, is the primary cause for the reported slippage/rotation during surgery. The cam body is supposed to fully sit on the bushing at all times in both locked and unlocked positions. The handle should always remain parallel to the field post when fully rotated to either end. The handle should only have the ability to rotate between 0? And 180? , even with the application of force. Forcing the handle beyond the 180? Range of motion (r. O. M) does not enhance the locking mechanism clamp subassembly? On the post. On the contrary doing so results in extra stresses being placed on the? Cam body? ,? Cam bolt bushing? And the? Handle? As well, leaving permanent deformation in its wake. As a result of this deformation, internal mating components lose the necessary contact/traction required to function as intended. As seen below, the end user forced the? Handle? Beyond the allowable r. O. M creating a significant indentation on the? Cam body? And handle. The amount of force used to form these deep indentations on the cam body and handle was so excessive that the circular? Cam bolt bushing? Became significantly deformed, as well as the cam feature on the? Handle?. Per the instructions for use (ifu) the end user is educated not to force the handle past the stop point;
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00081 |
| MDR Report Key | 5721308 |
| Report Source | USER FACILITY |
| Date Received | 2016-06-13 |
| Date of Report | 2016-05-17 |
| Date of Event | 2016-05-13 |
| Date Mfgr Received | 2016-06-13 |
| Device Manufacturer Date | 2016-04-11 |
| Date Added to Maude | 2016-06-13 |
| 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 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 | 2016-06-13 |
| Returned To Mfg | 2016-05-21 |
| 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 | 2016-06-13 |