MAUDE Adverse Event Report: STRYKER CORPORATION PRECISION THIN BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number 2296-003-125

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2022

Event Type  malfunction  

Event Description

Stryker precision thin (9.0-1250.38x31.0mm) ref# 2296-003, broke while passing back to scrub tech.Piece was present and was not at surgical site.Kept and labelled and removed from field.

• Brand Name: PRECISION THIN BLADE
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION; 3800 e. centre ave; portage MI 49002
• MDR Report Key: 15868400
• MDR Text Key: 304333654
• Report Number: 15868400
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/17/2022,08/18/2022

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
• Device Model Number: 2296-003-125
• Device Lot Number: 21291037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9125 DA
• Patient Sex: Female