MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-06-17 for OMNI-FLEX STERILE FIELD POST 10244 manufactured by Integra Lifesciences Corporation Oh/usa.
[47700383]
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
[47700384]
Customer initially reports post is rotating/ slipping during surgery. On (b)(6) 2016 customer reports the event occurred during a small bowel resection. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
[55226935]
On 8/26/2016 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - the customer? S complaint has been confirmed by engineering. 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 the locked position. It was also observed the knurling on the bolt cover apparently is prematurely worn down and rotates thereby allowing cam body to rotate. Lastly, there are indications on the cam housing and lever that shows potentially heavy force being used to lock the s. F. Clamp in place. There is a considerable amount of wear and tear present over the entire surface of the defective field post which would normally be expected from regular usage over a significant period of time. Additionally, during evaluation of the returned unit, engineering noticed that the field post would fully clamp onto the test rail, yet did observe lateral movement of the unit while under the application of force. Device history evaluation - device history record reviewed for this product id shows no abnormalities related to the reported failure. These devices passed all required inspection points with no associated mrr? S, variances or rework. No service history is on file for this device. Conclusion: upon further investigation into the customer? S complaint, engineering noticed the 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. It is noted that some portions of the post measure undersized in areas due to wear. A dysfunctional, likely bent, internal component within the. 75 serrated clamp assembly is likely the main cause for the s. F clamp subassembly not properly tightening onto the field post. 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. It is highly likely overexertion of force to lock the clamp is a major contributor and possible root cause for this failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00094 |
| MDR Report Key | 5733772 |
| Report Source | USER FACILITY |
| Date Received | 2016-06-17 |
| Date of Report | 2016-05-26 |
| Date of Event | 2016-05-19 |
| Date Mfgr Received | 2016-08-26 |
| Device Manufacturer Date | 2015-06-24 |
| Date Added to Maude | 2016-06-17 |
| 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 | 2016-06-17 |
| Returned To Mfg | 2016-07-08 |
| 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 | 2016-06-17 |