MAUDE Adverse Event Report: STRYKER /HOWMEDICA OSTEONICS CORP ACCESSORIES, ARTHROSCOPIC; CANNULATED SCREWDRIVER COUPLING

Model Number 45-20001

Device Problem Material Disintegration (1177)

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

Event Date 01/26/2023

Event Type  malfunction  

Event Description

On (b)(6)2023: pt was in surgery for a hammer toe correction.During the procedure the tip of a screwdriver disintegrated while in the patient's foot.The patient's foot was cleansed out with normal saline and metal debris as found were removed.A second screwdriver that had issues with its tip was found afterwards and removed before being used.Both screwdrivers were removed from the set.The tip of the drivers were both of the same brand/type.They came from the 2.0/3.0 micro asnis set.Stryker 45-20001-gtino4546540534385-1000371261, stryker 45-20001-gtino4546540534385-1000340587.See scanned pages.

• Brand Name: ACCESSORIES, ARTHROSCOPIC
• Type of Device: CANNULATED SCREWDRIVER COUPLING
• Manufacturer (Section D): STRYKER /HOWMEDICA OSTEONICS CORP
• MDR Report Key: 16337864
• MDR Text Key: 309306254
• Report Number: MW5114818
• Device Sequence Number: 1
• Product Code: HXX
• 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: 02/06/2023
• 2 Devices were Involved in the Event: 1 2

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
• Device Model Number: 45-20001
• Device Catalogue Number: 45-20001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White