MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-29 for OMNI-FLEX STERILE FIELD POST 10244 manufactured by Integra Lifesciences Corporation Oh/usa.
[71241918]
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
[71241919]
Bottom part of omni post (clamp) doesn't tighten down to bed rail. Exhibits movement. On 3/17/2017 no further information available.
Patient Sequence No: 1, Text Type: D, B5
[73848178]
On 4/10/17 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis - inspection confirmed complaint event. Device failed functional check, clamp shows slight movement when engaged. Visual examination of clamp jaw and post clamp reveal worn areas normal to operation of device. Engineer and service repair disassembled jaw from post, removed retaining washer and removed long bolt from post assembly. Unscrewing the long bolt from post assy, the service rep noticed a grating or grinding in the thread interface indicative of debris in threads. The debris in threads causing interference is most likely root cause of complaint event. Normal service for this device would be to run a thread die over the long bolt thread and chase the id threads with a tap, device history evaluation - device history record reviewed for this product id shows 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, see below. The following work orders encompass the devices manufactured with this lot code, see below. No service history is on file for this device. Conclusion: debris in threads causing interference is most likely root cause of complaint event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125289-2017-00004 |
| MDR Report Key | 6443516 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-29 |
| Date of Report | 2017-03-10 |
| Date Mfgr Received | 2017-04-10 |
| Device Manufacturer Date | 2016-01-27 |
| Date Added to Maude | 2017-03-29 |
| 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 | 2017-03-29 |
| Returned To Mfg | 2017-03-16 |
| Catalog Number | 10244 |
| Lot Number | 161 |
| 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 | 2017-03-29 |