MAUDE Adverse Event Report: JARIT / INTEGRA LIFESCIENCES CORPORATION MILTEX SELF-RETAINING RETRACTOR; RETRACTOR, SELF-RETAINING

Model Number 205-III

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2023

Event Type  Injury  

Event Description

After surgery finished and patient out of the operating room, scrub tech was cleaning up.St noticed that a screw was loose on a miltex retractor and attempted to tighten screw.In do so, the screw and hinge portion of the retractor fell off.In inspection of the whole miltex, the screw-hole of the hinge was missing less than 1mm portion of metal.Refer to additional documents in i2k¿.

• Brand Name: MILTEX SELF-RETAINING RETRACTOR
• Type of Device: RETRACTOR, SELF-RETAINING
• Manufacturer (Section D): JARIT / INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 17192193
• MDR Text Key: 317855606
• Report Number: MW5118724
• Device Sequence Number: 1
• Product Code: FFO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 205-III
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 96 YR
• Patient Sex: Female
• Patient Weight: 56 KG