MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-06-09 for SPEED-TRACT STERILE FIELD POST WITH COUPLER 11321 manufactured by Integra Lifesciences Corporation Oh/usa.
[46898492]
On 5/18/2016 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis: the customer? S complaint noted above has been confirmed by engineering. During evaluation of the returned unit, engineering noticed that the field post would not fully clamp onto the test rail. As the field post was being clamped onto the test rail, resistance was felt in the knob of the bolt subassembly which subsequently caused the field post to seize up completely. The unit would seize up and halt any further rotational movement of the knob. There is a considerable amount of wear and tear present over the entire surface of the defective field post which is expected from regular usage over a significant period of time. Device history evaluation: device history record reviewed for this product id shows no abnormalities related to the reported failure. The device manufactured with this lot code passed all required inspection points with no associated mrr? S, variances or rework. No service history is on file for this device. Conclusion: the presence of residual contaminates within the threads of the? Bolt? And the mating? Welded post subassembly, speed-tract? Are the primary causes for the observed resistance. The presence of these foreign contaminates are obstructing the mating threads during engagement, and as a result prevents the end user from properly/fully clamping the field posts onto the bed rail as stated. It? S likely the unit was not properly lubricated during post-cleaning inspections throughout its span of usage. The ifu instructs the end user to lubricate any? Metal to metal? Threading with a surgically acceptable lubricant in an effort to reduce frictional wear and tear of the components.
Patient Sequence No: 1, Text Type: N, H10
[46898493]
Customer initially reports post will not tighten to rail. On (b)(6) 2016 no further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2016-00090 |
| MDR Report Key | 5709257 |
| Report Source | USER FACILITY |
| Date Received | 2016-06-09 |
| Date of Report | 2016-02-09 |
| Date Mfgr Received | 2016-05-18 |
| Device Manufacturer Date | 2013-03-29 |
| Date Added to Maude | 2016-06-09 |
| 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 | SPEED-TRACT STERILE FIELD POST WITH COUPLER |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2016-06-09 |
| Returned To Mfg | 2016-02-25 |
| Catalog Number | 11321 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2016-06-09 |