MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELITE 17CM STRAIGHT ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	5407120485
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between october 1 ¿ december 31, 2025.This report summarizes 1 event for the failure: flaked.- 1 event had problem identified during non-clinical procedure; there was no patient involvement.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 1 event was reported for this quarter.Product return status 1 device was evaluated in the field.Evaluation findings (results/components) 1 device: material and/or chemical problem identified / coating material product disposition 1 device: product disposition is not yet determined additional information 1 device was not labeled for single-use.1 device was not reprocessed or reused.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2026-99189.Supplemental rationale.1 previously reported event was included in this follow-up record.Product return status: 1 device was evaluated in the field.Evaluation findings (results/components): 1 device: material and/or chemical problem identified / coating material.Product disposition: 1 device: scrapped by stryker.
Event or Problem Description
No change.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2026-99189.On 3/11/2026 stryker instruments discontinued the practice of filing mdrs for complaints related to material or pain chipping/flaking from attachment color band for devices registered under hbe product code in according to fda's "final guidance on medical device reporting for manufacturers" section 2.15.This malfunction has not caused or contributed to any serious injuries or deaths in at least two years.No new mdrs will be filed for this malfunction.
Event or Problem Description
No change.

• Brand Name: ELITE 17CM STRAIGHT ATTACHMENT
• 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: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 24164281
• Report Number: 3015967359-2026-99189
• Device Sequence Number: 13159208
• Product Code: HBE
• UDI-Device Identifier: 07613327096613
• UDI-Public: 07613327096613
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 1
• 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): 04/01/2026

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: 5407120485
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 12/31/2025; 12/31/2025
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 01/30/2026; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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