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 STANDARD WISHBONE ASSEMBLY 4020 manufactured by Integra Lifesciences Corporation Oh/usa.
[47489731]
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
[47489732]
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. Number 2 of 2 related complaints.
Patient Sequence No: 1, Text Type: D, B5
[55340081]
On 8/7/2016 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis: per the received 4020 wishbone assembly, the defective unit failed manufacturing checks 1, 2ii and 3. During evaluation, engineering registered a handle throw force of 31 lbs. Which is considerably above the recommended range of 8-15 lbs. The 4020 wishbone arms failed the rotational resistance functional check with accompanying resistance, grinding and squeaking noise as well. Furthermore engineering observed minimal grinding as the taper joint was being rotated per manufacturing check 3. There is considerable amount of wear and tear present on the surfaces of both received defective units. This is normal wear and tear expected from regular usage over time. Device history evaluation: device history record reviewed for this product id under lot code 157 shows no abnormalities related to reported incident found. These device passed all required inspection points with no associated mrr? S, variances or rework. Conclusion: in regards to the 4020 wishbone assembly, the defective unit is being returned for the third time with previous servicing performed only once. The unit did not require any further servicing. 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 overtightened yet there aren? T any signs indicating the 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 | 2523190-2016-00089 |
| MDR Report Key | 5727904 |
| 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 | STANDARD WISHBONE ASSEMBLY |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | FFO |
| Date Received | 2016-06-15 |
| Returned To Mfg | 2016-05-27 |
| Catalog Number | 4020 |
| 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 |