MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 SMALL ASEPTIC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 6127120000

Device Problem Biocompatibility (2886)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Two devices were received for evaluation and the reported events were confirmed.The devices were found to be affected by a migrated o-ring.One device is available for evaluation but has not yet been evaluated.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 3 malfunction events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.Two reported events had no patient involvement; no patient impact.One reported event had patient involvement; no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).There were no remedial actions taken.This device is not labeled for single-use.Correction: 1 device was anticipated for return; however, the device was not received by stryker.

Event Description

This report summarizes 3 malfunction events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.Two reported events had no patient involvement; no patient impact.One reported event had patient involvement; no patient impact.

• Brand Name: SYSTEM 6 SMALL ASEPTIC HOUSING
• 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: 6279998
• MDR Text Key: 66120078
• Report Number: 0001811755-2017-00252
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

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: 6127120000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: 09/01/2016
• Supplement Dates FDA Received: 09/01/2017
• 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