MAUDE Adverse Event Report: STRYKER INSTRUMENTS STRYKER RECIPROCATING SAW BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 0277-096-275

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Reciprocating saw blade stem tabs broke off during a primary tka.Fda safety report id #(b)(4).

• Brand Name: STRYKER RECIPROCATING SAW BLADE
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 15800113
• MDR Text Key: 303807049
• Report Number: MW5113267
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 0277-096-275
• Device Lot Number: 22252017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male