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

Catalog Number 4408000000

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).One device was available for evaluation but has not yet been received.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 1 malfunction event in which the device had a sticking trigger.There was no patient involvement; no patient impact.

Manufacturer Narrative

(b)(4).1 device was received for evaluation.1 event was confirmed during testing as having sticky triggers.The device was found to be affected by damaged handle components.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 1 malfunction event in which the device had a sticking trigger.There was 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: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6747881
• MDR Text Key: 81430967
• Report Number: 0001811755-2017-01416
• Device Sequence Number: 1
• Product Code: HWE
• 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,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4408000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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