MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP CORDLESS DRIVER 4 HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 4405000000

Device Problem Fluid/Blood Leak (1250)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2020

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: 7 events were reported for this quarter.Product return status: 7 device investigation types have not yet been determined.Additional information: 7 devices were not labeled for single-use.7 devices were not reprocessed or reused.

Event Description

This report summarizes 7 malfunction events in which the device was reportedly leaking.6 events had no patient involvement; no patient impact.1 event had insufficient information received.

Event Description

This report summarizes 6 malfunction events in which the device was reportedly leaking.5 events had no patient involvement; no patient impact.1 event had insufficient information received.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 7 events were previously reported during the reporting period; however, 1 previously reported event in this report should have been included under mfr report # 0001811755-2021-00419.6 previously reported events are included in this follow-up record.Product return status: 4 devices were received.2 device investigation types have not yet been determined.

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 6 previously reported events are included in this follow-up record.Product return status 6 devices were received.

Event Description

This report summarizes 6 malfunction events in which the device was reportedly leaking.- 6 events had no patient involvement; no patient impact.

• Brand Name: CORDLESS DRIVER 4 HANDPIECE
• 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: 11215829
• MDR Text Key: 228488425
• Report Number: 0001811755-2021-00286
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613252481355
• UDI-Public: 07613252481355
• Combination Product (y/n): N
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,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: 4405000000
• Device Catalogue Number: 4405000000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 12/31/2020; 12/31/2020
• Supplement Dates FDA Received: 04/30/2021; 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1