MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SABO2 SAG SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4408000000

Device Problem Unintended Power Up (1162)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events: 1 event was reported for this quarter.  product return status: 1 device was received for evaluation.Evaluation status: 1 event was not confirmed during testing; the device was found to be within specifications.Additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.

Event Description

This report summarizes 1 malfunction event in which the device ran without user activation.1 event had no patient involvement; no patient impact.

• Brand Name: SABO2 SAG SAW
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 8013991
• MDR Text Key: 125443392
• Report Number: 0001811755-2018-01862
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613252481478
• UDI-Public: 07613252481478
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4408000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1