MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMARTLIFE LARGE ASPETIC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 7126120000

Device Problem Biocompatibility (2886)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).The 41 devices were received for evaluation; 38 events were confirmed during testing.15 devices were found to be affected by a compromised weld.The 7 devices were found to be separated at the weld site.The 8 devices were found to be affected by a swollen o-ring.The 3 devices were found to be fractured.The 1 device had a damaged o-ring.The 1 device had a swollen o-ring and a damaged component.The 1 device was found to have a missing o-ring and a compromised weld.The 1 device was found to have a cracked housing and a missing o-ring.The 1 device was found to have the hinge broken off, resulting in the lid detaching.The reported event was not confirmed for 2 devices; the devices were found to be within specifications for the reported event.The 1 device evaluation is in progress.The 9 devices are available for evaluation but have not yet been received.The 6 devices were not available to stryker for evaluation.The 18 of 56 reported devices are in scope of ra2016-193 for replace.The6 of 56 reported devices are in scope of ra2016-193 for notification.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 56 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.The 32 reported events had no patient involvement; no patient impact.The 24 reported events had patient involvement with no patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).Eight devices were received for evaluation.Three events were confirmed that the housing weld was compromised.The reported event was not confirmed for 5 devices; the devices were found to be within specifications for the reported event.This device is not labeled for single-use.Correction: four devices were initially not expected to be returned for evaluation; however, the 4 devices were received.Six devices were initially expected to be returned for evaluation; however, the devices were not received.

Event Description

This report summarizes 56 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.Thirty two reported events had no patient involvement; no patient impact.Twenty four reported events had patient involvement with no patient impact.

• Brand Name: SMARTLIFE LARGE ASPETIC 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: 6526561
• MDR Text Key: 74069871
• Report Number: 0001811755-2017-01129
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 56
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

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: 7126120000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 12/02/2016
• Supplement Dates FDA Received: 10/13/2017
• 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
• Removal/Correction Number: RA2016-193
• Patient Sequence Number: 1