MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYS 7 HIGH SPEED PRECISION SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 7209009000

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the (b)(6), exemption number (b)(4).Six devices were received for evaluation; 6 events were confirmed during testing.Four devices were found to be affected by corrosion.Two devices were found to have corrosion and trigger contamination.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 6 malfunction events in which the safety of the device would not work, creating the potential for unintended activation.There was no patient involvement; no patient impact.

• Brand Name: SYS 7 HIGH SPEED PRECISION 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5830490
• MDR Text Key: 51508927
• Report Number: 0001811755-2016-01352
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 7209009000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 07/28/2016
• 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