MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2.2MM LINDEMANN DRILL BIT; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 1608002043

Device Problem Fracture (1260)

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

Event Date 12/31/2023

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: 5 events were reported for this quarter.Product return status: 5 device investigation types have not yet been determined.Additional information: 5 devices were labeled for single-use.5 devices were not reprocessed or reused.

Event Description

This report summarizes 5 malfunction events in which the device or cutting accessory fractured.- 5 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: h6, h11 5 previously reported events are included in this follow-up record.Product return status 5 devices were received.

Event Description

This report summarizes 5 malfunction events in which the device or cutting accessory fractured.- 5 events had patient involvement; no patient impact.

• Brand Name: 2.2MM LINDEMANN DRILL BIT
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18556846
• MDR Text Key: 333405103
• Report Number: 3015967359-2024-00164
• Device Sequence Number: 1
• Product Code: GFF
• UDI-Device Identifier: 04546540030597
• UDI-Public: 04546540030597
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1608002043
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1