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 Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/25/2018

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 44 events were reported for this quarter.Product return status: 38 devices were received.2 devices were not available for evaluation.4 device investigation types have not yet been determined.  evaluation status: confirmed 1 reported event was confirmed during testing.1 device was found to be affected by a missing latch cam and screw.In progress: 37 device evaluations are in progress.Additional information: 44 devices were not labeled for single-use.44 devices were not reprocessed and reused.

Event Description

This report summarizes 44 malfunction events in which the device difficult to open or close.1 event had no known patient involvement or patient impact.43 events had patient involvement; no patient impact.

Event Description

This report summarizes 43 malfunction events in which the device difficult to open or close.43 events had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 44 events were previously reported during the reporting period; however, 1 previously reported event in this report was subsequently reported under mfr report # 0001811755-2019-00715.43 previously reported events are included in this follow-up record.Product return status: 38 devices were received.5 devices were not available for evaluation.Event confirmation status: 8 reported events were confirmed.30 reported events were not confirmed.Evaluation results: 7 devices were found to be affected by a damaged o-ring 1 device was found to be affected by a missing latch cam and screw.30 devices had no problem found.Additional information: 43 devices were not labeled for single-use.43 devices were not reprocessed and reused.

• 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
• MDR Report Key: 8285064
• MDR Text Key: 134469915
• Report Number: 0001811755-2019-00357
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327128819
• UDI-Public: 7613327128819
• Combination Product (y/n): N
• Number of Events Reported: 43
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

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
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/25/2018
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 12/25/2018
• Supplement Dates FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1