MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-31 for RATCHET MECHANISM, FEMUR ELEVATOR 11500 manufactured by Integra Lifesciences Corporation Oh/usa.
[53565777]
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
[53565778]
Customer initially reports that the unit slips and will not hold tension. On (b)(6) 2016 customer reports no harm, no damage and no further information available.
Patient Sequence No: 1, Text Type: D, B5
[59390406]
On 10/4/2016 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis - the customer? S complaints noted above has been confirmed by engineering. The received unit failed manufacturing check 2 per 1101-11502r. 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. Also the clamp? S subassembly handle does not align parallel to the field post in both locked and unlocked positions. Furthermore, the customer? S complaint in regards to the post being mis-etched has also been confirmed. The received defective unit is indeed an 11502r? Sterile field post and arm, femur elevator? Yet was inadvertently mis-etched internally as a 10244? Omni-flex sterile field post? Lastly, in regards to the received 11500? Ratchet mechanism, femur elevator? The unit passed all applicable functional tests per 1101-11500 with the exception of noticeable grinding as manufacturing check 2 was being executed. Device history evaluation - device history record reviewed for this product id under lot codes 159 and 154 respectively show no abnormalities related to reported incident found. This device passed all required inspection points with no associated mrr? S, variances or rework. Conclusion: upon further investigation into the customer? S complaint, engineering noticed the s. F. Clamp subassembly was not functioning properly as designed. The s. F clamp subassembly primarily comprises of two clamps, a. 50 serrated clamp and a. 75 serrated clamp 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 yet the handle does not align parallel to the field post. A dysfunctional, likely bent, internal component within the. 50 serrated clamp assembly is likely the main cause for the s. F clamp subassembly not properly tightening onto the field post. The cam body is supposed to fully sit on the bushing at all times in both locked and unlocked positions. The handle should always remain parallel to the field post when fully rotated to either end. The handle should only have the ability to rotate between 0? And 180? , even with the application of force. It is highly likely overexertion of force to lock the clamp is a major contributor and possible root cause for this failure, based on the indications on the 4047011 cam body and 10480 handle.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125289-2016-00008 |
| MDR Report Key | 5917134 |
| Report Source | USER FACILITY |
| Date Received | 2016-08-31 |
| Date of Report | 2016-08-12 |
| Date Mfgr Received | 2016-10-04 |
| Date Added to Maude | 2016-08-31 |
| 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 | RATCHET MECHANISM, FEMUR ELEVATOR |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2016-08-31 |
| Returned To Mfg | 2016-08-25 |
| Catalog Number | 11500 |
| 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 | 2016-08-31 |