MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 RECIP SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 7206000000

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Six devices were received for evaluation; 6 events were confirmed during testing.Six devices were found to be affected by corrosion of internal components.One device is available for evaluation but has not yet been evaluated.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 7 malfunction events in which the safety of the device was stuck, presenting a condition in which the device could be inadvertently activated.There was no patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the (b)(4) pilot program, exemption number (b)(4).Two (2) devices were not available to stryker for evaluation, though originally expected.There were no remedial actions taken.This device is not labeled for single-use.Device not returned.

Event Description

This report summarizes 7 malfunction events in which the safety of the device was stuck, presenting a condition in which the device could be inadvertently activated.There was no patient involvement; no patient impact.

• Brand Name: SYSTEM 7 RECIP 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: 5830470
• MDR Text Key: 51492532
• Report Number: 0001811755-2016-01371
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 7
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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: 7206000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: No
• 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