MAUDE Adverse Event Report: SYMMETRY MEDICAL MANUFACTURING INC. SYMMETRY SURGICAL NEEDLE DRIVER; HOLDER, NEEDLE, ORTHOPEDIC

Device Problems Problem with Sterilization (1596); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2019

Event Type  Injury  

Event Description

Black residue identified on jaws of needle holders with tungsten carbide inserts.Residue found after instruments had been through the sterilization process but prior to start of surgical procedure.Black residue tested and found to be negative for bioburden.Micro performed on the substance is negative.This was able to be replicate with multiple needle holders of various sizes by wiping with cloth soaked in saline.Composition of black residue unk at this time.Fda safety report id# (b)(4).

• Brand Name: SYMMETRY SURGICAL NEEDLE DRIVER
• Type of Device: HOLDER, NEEDLE, ORTHOPEDIC
• Manufacturer (Section D): SYMMETRY MEDICAL MANUFACTURING INC.; warsaw IN 46582
• MDR Report Key: 9166216
• MDR Text Key: 161602168
• Report Number: MW5090247
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 10/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention