MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-19 for FASTSYSTEM STERILE FIELD POST 4080 manufactured by Integra Lifesciences Corporation Oh/usa.
[50715638]
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
[50715639]
It was reported that the complaint was originally to fix a retractor that was becoming loose on larger patients during surgery. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[57607994]
Integra has completed their internal investigation on september 1st, 2016. The investigation included: methods: evaluation of actual device. Review of device history records. Review of complaints history. Results: evaluation of returned device; the s. F clamp subassembly primarily comprises of a 4044011. 75 serrated clamp and a 4043011. 50 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. The received field post exhibited signs of misuse with clear indications on the 4047011 cam body and the 10480 handle subassembly. Dhr review; no abnormalities related to reported incident found. Complaints history; no additional complaints in a two year look-back conclusion: 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00117 |
| MDR Report Key | 5807432 |
| Date Received | 2016-07-19 |
| Date of Report | 2016-06-28 |
| Date Mfgr Received | 2016-09-01 |
| Date Added to Maude | 2016-07-19 |
| 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 SONIA IRIZARRY |
| 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 | 2016-07-19 |
| Catalog Number | 4080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-07-19 |