MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PERFORATOR CHUCK; MOTOR, DRILL, PNEUMATIC

Model Number 5400210060

Device Problem Overheating of Device (1437)

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

Event Date 09/30/2022

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 33 events were reported for this quarter.Product return status 25 devices were received.1 device was not available for evaluation.7 device investigation types have not yet been determined.Additional information 33 devices were not labeled for single-use.33 devices were reprocessed or reused.

Event Description

This report summarizes 33 malfunction events in which the device reportedly overheated.25 events had no patient involvement; no patient impact.8 events had patient involvement; no patient impact.

Event Description

This report summarizes 33 malfunction events in which the device reportedly overheated.- 25 events had no patient involvement; no patient impact.- 8 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: h10 33 previously reported events are included in this follow-up record.Product return status 27 devices were received.4 devices were not available for evaluation.2 device investigation types have not yet been determined.Additional information 33 devices were not reprocessed or reused.

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,h6,h10 33 previously reported events are included in this follow-up record.Product return status 27 devices were received.6 devices were not available for evaluation.

Event Description

This report summarizes 33 malfunction events in which the device reportedly overheated.- 27 events had no patient involvement; no patient impact.- 6 events had patient involvement; no patient impact.

• Brand Name: PERFORATOR CHUCK
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 15666733
• MDR Text Key: 302695923
• Report Number: 3015967359-2022-02117
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 04546540469229
• UDI-Public: 04546540469229
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 33
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2023

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 Model Number: 5400210060
• Device Catalogue Number: 5400210060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 09/30/2022; 09/30/2022
• Supplement Dates FDA Received: 01/30/2023; 07/27/2023
• 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
• Patient Sequence Number: 1