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

Catalog Number 4020

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that during abdominal surgery, there was breakage of the standard wishbone assembly (4020).It was reported that the medical staff was able to finish the procedure.There was approximately a 30-minute increase in surgery time; however, no patient injury occurred.

Manufacturer Narrative

Failure analysis: after evaluation, the handle assembly was replaced along with some needed small parts (cam bearings, cam bolt, cam bushing).The nut, washer and ring were replaced for routine overhaul.Both wishbone arm assemblies were replaced.The unit has been subjected to a successful function check.Root cause analysis: based on the evaluation by integra service and repair, the root cause is most likely mishandling of the product leading to damages.No manufacturing, workmanship, or material deficiency was identified for correction as a result of this complaint investigation.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16773296
• MDR Text Key: 313816678
• Report Number: 3004608878-2023-00071
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2023
• 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