MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-10-28 for OMNI-FLEX STERILE FIELD POST 10244 manufactured by Integra Lifesciences Corporation Oh/usa.
[58718290]
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
[58718291]
Post is rotating/ slipping during surgery. On (b)(6) 2016 customer has no further information.
Patient Sequence No: 1, Text Type: D, B5
[65930788]
Integra has completed their internal investigation on 12/21/2016. The investigation included: device history record reviewed for this product id lot #161 manufactured on april 11, 2016, lot# 164 manufactured on june 19, 2016 and lot# 167 manufactured on october 05, 2016 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. Engineering noticed the s. F. Clamp subassembly (p/n 4088021) was not functioning properly as designed. The s. F clamp subassembly primarily comprises of two. 75 serrated clamps (p/n 4044011), 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 (p/n 4047011) does not fully sit on the bushing (p/n 4103011) between the. 75 serrated clamp and cam body as it should. Dysfunctional internal components within and on the 4088021? S. F. Clamp subassembly,. 75 x. 75 serrated? , due to user error, is the primary cause for the reported slippage/rotation during surgery. There? S a possibility that the 4088021? S. F clamp subassembly? Prematurely failed due to initial galling which could of occurred during our internal assembly process, causing loss of functionality as extensive galling/wear is enhanced as the handle is exercised over time. Per the instructions for use (ifu) the end user is educated not to force the handle past the stop point; capa has been issued to address the non-conformance above, and to help adopt measures to help prevent any future reoccurrences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125289-2016-00009 |
| MDR Report Key | 6065026 |
| Report Source | USER FACILITY |
| Date Received | 2016-10-28 |
| Date of Report | 2016-10-03 |
| Date Mfgr Received | 2016-12-21 |
| Device Manufacturer Date | 2016-04-11 |
| Date Added to Maude | 2016-10-28 |
| 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 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 | 2016-10-28 |
| Returned To Mfg | 2016-10-14 |
| 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 | 2016-10-28 |