MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-02 for OMNI-FLEX STERILE FIELD POST 10244 manufactured by Integra Lifesciences Corporation Oh/usa.
[51003436]
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
[51003437]
Customer initially reports.. Post is rotating/ slipping during surgery. On (b)(6) 2016 customer reports an exploratory laparotomy was being performed. Device has been previously used. No idea how long device in use during this procedure before the event occurred. No harm done.
Patient Sequence No: 1, Text Type: D, B5
[52777349]
On 8/11/16 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 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. 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: 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. Capa has been issued to address the non-conformance above, and to help determine the actual root cause and adopt measures to help prevent any future reoccurrences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00112 |
| MDR Report Key | 5841742 |
| Report Source | USER FACILITY |
| Date Received | 2016-08-02 |
| Date of Report | 2016-06-29 |
| Date Mfgr Received | 2016-08-11 |
| Device Manufacturer Date | 2015-06-24 |
| Date Added to Maude | 2016-08-02 |
| 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 | 2016-08-02 |
| 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 | 2016-08-02 |