MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA STANDARD WISHBONE ASSEMBLY; SURGICAL RETRACTOR

Catalog Number 4020

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: STANDARD WISHBONE ASSEMBLY
• Type of Device: SURGICAL RETRACTOR
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5807095
• MDR Text Key: 50715584
• Report Number: 2523190-2016-00116
• Device Sequence Number: 1
• Product Code: FFO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4020
• Device Lot Number: 157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1