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

Model Number 7222120000

Device Problem Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2020

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: 13 events were reported for this quarter.Product return status: 3 devices were received.10 device investigation types have not yet been determined.Event confirmation status: 3 reported events were confirmed.Evaluation results: 3 devices were found to be affected by a missing o-ring.13 devices were not labeled for single-use.13 devices were not reprocessed or reused.

Event Description

This report summarizes 13 malfunction events in which the device was reportedly difficult to open or close.13 events had patient involvement; no patient impact.

Event Description

This report summarizes 13 malfunction events in which the device was reportedly difficult to open or close.- 13 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: 13 previously reported events are included in this follow-up record.Product return status: 8 devices were received.5 device investigation types have not yet been determined.Event confirmation status: 8 reported events were confirmed.Evaluation results: 7 devices were found to be affected by a missing o-ring.1 device was found to be affected by a damaged latch plate/latch cam.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 13 previously reported events are included in this follow-up record.Product return status: 8 devices were received.5 devices were not available for evaluation.

Event Description

This report summarizes 13 malfunction events in which the device was reportedly difficult to open or close.1 event had no patient involvement: no patient impact.12 events had patient involvement: no patient impact.

• Brand Name: SMARTLIFE SMALL ASPTC 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: 10331391
• MDR Text Key: 200624194
• Report Number: 0001811755-2020-01949
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327128789
• UDI-Public: 07613327128789
• Combination Product (y/n): N
• Number of Events Reported: 13
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7222120000
• Device Catalogue Number: 7222120000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1