MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE 12CM STRAIGHT ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 5407120470

Device Problem Flaked (1246)

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

Event Date 09/30/2023

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 67 events were reported for this quarter.Product return status 67 devices were evaluated in the field.Additional information 67 devices were not labeled for single-use.67 devices were not reprocessed or reused.

Event Description

This report summarizes 67 malfunction events in which the device had paint chips missing.67 events had no patient involvement; no patient impact.

• Brand Name: ELITE 12CM STRAIGHT ATTACHMENT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17992941
• MDR Text Key: 326369634
• Report Number: 3015967359-2023-02311
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 07613327096569
• UDI-Public: 07613327096569
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 67
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2023

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 Catalogue Number: 5407120470
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2023
• Initial Date FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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