MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-19 for STANDARD WISHBONE ASSEMBLY 4020 manufactured by Integra Lifesciences Corporation Oh/usa.
[50715584]
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
[50715625]
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
[56308673]
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 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. Dhr review; device history record reviewed for this product id under lot code 157 show no abnormalities related to reported incident found. These device passed all required inspection points with no associated mrr? S, variances or rework complaints history; a two year lookback for this reported failure and or related to " loose on larger patients during surgery, parts not readily available and loaners not available for this product family" for this product id shows that no additional complaints were received. No new design or manufacturing trends have been identified. This issue will be monitored. Conclusion: 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. The unit demonstrates signs of being over tightened yet there aren? T any signs indicating the 4032011 nut being tampered with while out in the field. 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 | 2523190-2016-00116 |
| MDR Report Key | 5807095 |
| 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 | STANDARD WISHBONE ASSEMBLY |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2016-07-19 |
| Returned To Mfg | 2016-08-31 |
| Catalog Number | 4020 |
| Lot Number | 157 |
| 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 | 2016-07-19 |