MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-06-15 for FASTSYSTEM STERILE FIELD POST 4080 manufactured by Integra Lifesciences Corporation Oh/usa.
[47489600]
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
[47489601]
Doctor initially reports that cam lever lock on sterile field post is too easy to engage and not holding wish bone in place. On (b)(6) 2016 customer reports that the surgeon was performing an anterior spinal discectomy with fusion when soon into the procedure the device failed to hold position. No harm done confirmed. #1 of 2 related complaints.
Patient Sequence No: 1, Text Type: D, B5
[53720552]
On 8/7/16 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis - the customer? S complaint has been confirmed by engineering. Device history evaluation - device history record reviewed for this product id shows no abnormalities related to reported incident found. These device passed all required inspection points with no associated mrr? S, variances or rework. Conclusion: the customer? S complaint has been confirmed by engineering. The defective sterile field post was previously returned for servicing due to loss of functionality in the clamping mechanism. The servicing department subsequently replaced the handle subassembly along with deformed/fatigued and bushings, and the retaining washer to aide in the disassembly efforts. The unit is now being returned for the second time for the same failure mode. Upon further investigation into the customer? S recent complaint, engineering noticed the s. F. Clamp subassembly was not functioning properly as designed. The received field post exhibited signs of misuse with clear indications on the cam body and the handle subassembly. It? S apparent the end user overexerted force on the handle during locking motion, which subsequently caused permanent deformation on the cam body and handle. In regards to the 4020 wishbone assembly, the defective unit is being returned for the third time. The received unit is now exhibiting signs of excessive resistance during the handle throw motion and the rotational resistance of the wishbone arms through their entire range. The root cause for the observed failure cannot be fully determined. Furthermore, the unit was completely disassembled with no signs of internal component deformations which could be identified as a contributing factor to the observed failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00088 |
| MDR Report Key | 5727905 |
| Report Source | USER FACILITY |
| Date Received | 2016-06-15 |
| Date of Report | 2016-05-26 |
| Date of Event | 2016-05-23 |
| Date Mfgr Received | 2016-08-07 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2016-06-15 |
| 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 | FASTSYSTEM STERILE FIELD POST |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2016-06-15 |
| Returned To Mfg | 2016-05-27 |
| Catalog Number | 4080 |
| 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 | 2016-06-15 |