MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP NON FOOTED ATTACHMENT 9CM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	5407-NFA-9CM
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional 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: 1 device was received.6 devices were evaluated in the field.Additional information: 7 devices were not labeled for single-use.7 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 7 malfunction events in which the device had paint chips missing.7 events had no patient involvement; no patient impact.
Event or Problem Description
This report summarizes 8 malfunction events in which the device had paint chips missing.8 events had no patient involvement; no patient impact.
Additional 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 originally reported for this failure mode during the reporting quarter; however, 1 event was inadvertently excluded.8 reported events are included in this follow-up record.Product return status: 2 devices were received.6 devices were evaluated in the field.
Additional 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 8 previously reported events are included in this follow-up record.Product return status 8 devices were evaluated in the field.
Event or Problem Description
This report summarizes 8 malfunction events in which the device had paint chips missing.- 8 events had no patient involvement; no patient impact.

• Brand Name: NON FOOTED ATTACHMENT 9CM
• Common Device Name: 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: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12679874
• Report Number: 3015967359-2021-02234
• Device Sequence Number: 17137159
• Product Code: HBE
• UDI-Device Identifier: 07613327096446
• UDI-Public: 07613327096446
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 8
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2022

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: 5407-NFA-9CM
• Device Catalogue Number: 5407NFA9CM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 09/30/2021; 09/30/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 10/28/2021; 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown