MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-29 for MULIER HIP RETRACTOR, 1 4594 manufactured by Integra Lifesciences Corporation Oh/usa.
[54206821]
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
[54206822]
Customer purchased the omni hip system including the abh style listed above. Abh blade connectors have begun to come apart from the blade. These should stay intact with the retractor blade. Once these came apart customer noticed that bioburden was collecting where these should be connected. On (b)(6) 2016 customer reports his occurred during a total hip replacement and although there was no harm there was potential. No further information available. #1 of 5 related complaints.
Patient Sequence No: 1, Text Type: D, B5
[57948139]
On 9/19/2016 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - the customer? S complaint could not be confirmed by engineering as the physical product was not received for proper evaluation/ investigation. According to the customer, their mulier/meyerding hip retractors have come apart. These retractors comprise of two main components (i. E. A slotted blade and attachment) that get press fitted together to form the final assembly build. Device history evaluation - device history record reviewed for this product id a total of 2 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. No service history is on file for this device. Conclusion: engineering is yet to receive the defective units for proper evaluation/investigation. As such, the complaint cannot be fully confirmed at the moment. It should however be noted that the customer previously reached out to our sales representative prior to this official complaint stating the following :? Apparently one of the spd folks at an account was trying to remove a blade from our abh holder prior to cleaning, and in doing so, actually popped the nipple component out. The customer then apparently thought that this was a requirement for cleaning the abh blades, and proceeded to break apart all remaining blades prior to cleaning. Interestingly? They found bioburden inside the components after taking the components apart?.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125289-2016-00001 |
| MDR Report Key | 5910437 |
| Date Received | 2016-08-29 |
| Date of Report | 2016-07-28 |
| Date Mfgr Received | 2016-09-19 |
| Device Manufacturer Date | 2014-01-29 |
| Date Added to Maude | 2016-08-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MULIER HIP RETRACTOR, 1 |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2016-08-29 |
| Catalog Number | 4594 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-08-29 |