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

Event Date 06/30/2023

Event Type  malfunction  

Event Description

This report summarizes 6 malfunction events in which the device or cutting accessory fractured.(b)(4) events had patient involvement; no patient impact.(b)(4) events 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.Reported events (b)(4) events were reported for this quarter.Product return status (b)(4) devices were not available for evaluation.(b)(4) device investigation types have not yet been determined.Additional information (b)(4) devices were labeled for single-use.(b)(4) devices were not reprocessed or reused.

Event Description

This report summarizes 6 malfunction events in which the device or cutting accessory fractured.- 3 events had patient involvement; no patient impact.- 3 events 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 corrected data: h6, h10 6 previously reported events are included in this follow-up record.Product return status 1 device was received.5 devices were not available for evaluation.

• 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-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: 17399004
• MDR Text Key: 320038188
• Report Number: 3015967359-2023-01631
• 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: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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