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

Model Number 7126-120-000

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

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, eight (8) events were reported for this quarter.Product return status six (6) devices were received.One (1) device was not available for evaluation.One (1) device investigation type has not yet been determined.Additional information, eight (8) devices were not labeled for single-use.Eight (8) devices were not reprocessed or reused.

Event Description

This report summarizes 8 malfunction events in which the device was reportedly difficult to open or close.Two (2) events had no patient involvement, no patient impact.Six (6) 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 corrected data: b5, h10 8 events were originally reported for this failure mode during the reporting quarter; however, 2 events were inadvertently excluded.10 reported events are included in this follow-up record.Product return status: 6 devices were received.4 devices were not available for evaluation.

Event Description

This report summarizes 10 malfunction events in which the device was reportedly difficult to open or close.2 events had no patient involvement; no patient impact.8 events had patient involvement; 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-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11729051
• MDR Text Key: 249710513
• Report Number: 3015967359-2021-00662
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327128819
• UDI-Public: 07613327128819
• Combination Product (y/n): N
• Number of Events Reported: 10
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

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 Model Number: 7126-120-000
• Device Catalogue Number: 7126120000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/01/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 01/01/2021
• Supplement Dates FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1