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

Model Number 0277096281

Device Problems Break (1069); Product Quality Problem (1506)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

Saw blade broke.Both pieces accounted for by md, surgical technician, and circulator.Catalog# 0277096281, lot# 22258017.Manufacturer response for saw blade, saw blade (per site reporter) site reached out to rep due to md saying this is a recurrent issue.

• Brand Name: SAW 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: 15814115
• MDR Text Key: 303810795
• Report Number: 15814115
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 0277096281
• Device Catalogue Number: 0277-096-281
• Device Lot Number: 22258017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1