MAUDE Adverse Event Report: STRYKER CORP. LEFT IBO BLADE; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Lot Number 17157017

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/31/2018

Event Type  malfunction  

Event Description

During the procedure the saw head from the saw blade broke from the stem.The broken blade was checked and it was intact, no other fragments of the equipment found.Fda safety report id# (b)(4).

• Brand Name: LEFT IBO BLADE
• Type of Device: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER CORP.
• MDR Report Key: 8514570
• MDR Text Key: 142214041
• Report Number: MW5085840
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): Y
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Lot Number: 17157017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 20 YR
• Patient Weight: 84