MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LEFT IBO BLADE (10.0 X 0.38MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number 5100037902

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Awaiting device return.

Event Description

It was reported that the blade broke at the distal end during a procedure.No further information was provided.

Event Description

It was reported that the blade broke at the distal end during a procedure.No further information was provided.

Manufacturer Narrative

H6; the blade reported involved in this event was not returned for evaluation.However, photographic evidence was provided of a broken blade where the reported event of blade breakage was confirmed.Without the blade, the root cause cannot be determined.Device not available for return.

• Brand Name: LEFT IBO BLADE (10.0 X 0.38MM)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9606736
• MDR Text Key: 175712178
• Report Number: 0001811755-2020-00098
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540466822
• UDI-Public: 04546540466822
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: 5100037902
• Device Catalogue Number: 5100037902
• Device Lot Number: 18213017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1