MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-08-14 for STANDARD WISHBONE ASSEMBLY 4020 manufactured by Integra Lifesciences Corporation Oh/usa.
[82712104]
On 8/7/17 integra investigation completed. Manufacture date unknown. Method: failure analysis, device history evaluation. Results: failure analysis - during investigation the following was observed: evaluation verified customer information as valid. The pressure of the locking mechanism is too low. Small parts are worn. Marked with individual item number. Device history evaluation - no abnormalities relate to reported incident found nor where there any variances, mrr? S or reworks associated with this lot/work order number. No service history on file. Conclusion: failure analysis to identify root cause confirmed complaint event. Upon incoming analysis device failed functional testing, loose clamping. (b)(4) service center identified worn parts and replaced them. Root cause most likely wear and tear.
Patient Sequence No: 1, Text Type: N, H10
[82712105]
Customer reports to small locking force in the locking mechanism. Arms are moving under tissues pressure of patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125289-2017-00009 |
| MDR Report Key | 6793218 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-08-14 |
| Date of Report | 2017-07-14 |
| Date Mfgr Received | 2017-07-14 |
| Date Added to Maude | 2017-08-14 |
| 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 | STANDARD WISHBONE ASSEMBLY |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2017-08-14 |
| Returned To Mfg | 2017-07-20 |
| Catalog Number | 4020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-08-14 |