MAUDE Adverse Event Report: JARIT/INTEGRA LIFE SCIENCES / INTEGRA LIFESCIENCES CORPORATION JARIT 6" NEEDLE DRIVER; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

During surgery, while using 6" needledrivers x2, it was noticed that a 2mm piece of each needledriver missing.Search of sterile and unsterile fields.Not found.Mini c-arm imaging of surgical site, left foot was completed twice and read by surgeon as negative for each of the missing pieces.The needledrivers were obtained by clinician.No harm to patient.Ref report: mw5148232.

• Brand Name: JARIT 6" NEEDLE DRIVER
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): JARIT/INTEGRA LIFE SCIENCES / INTEGRA LIFESCIENCES CORPORATION; princeton NJ 08540
• MDR Report Key: 18159177
• MDR Text Key: 328526107
• Report Number: MW5148233
• Device Sequence Number: 1
• Product Code: DWS
• 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: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White