MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD UNKNOWN JARIT; N/A

Catalog Number XXX-JARIT

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

This is 1 of 2 reports for the 1st device reportedly used during this event.This report is linked to mfg# 3014334038-2023-00201.The following was received via mdr report #: mw5148232: "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: mw5148233.".

Manufacturer Narrative

The medwatch report was received with no initial reporter or reporting facility contact details; thus, additional information could not be requested.No further information or product return has been provided to the manufacturer.

Event Description

N/a.

Manufacturer Narrative

Updated field: d9, g3, g6, h2, h3, h6, h10 the complaint product, unknown jarit needle holder was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.Definitive root cause of the reported issue could not be determined.The issue of missing a piece may be the result of disassembly or breakage due to rough handling/environmental damage.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation will be performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.H3 other text : 02.

• Brand Name: UNKNOWN JARIT
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18422911
• MDR Text Key: 331671198
• Report Number: 3014334038-2023-00200
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: XXX-JARIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2024
• 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