MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MD SERIES LONG STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL

Catalog Number	5100015270
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: 2 events were reported for this quarter.Product return status: 2 devices were received.Evaluation findings (results/components): 1 device: no device problem found / part/component/sub-assembly term not applicable.1 device: wear problem / housing, spring.Product disposition: 2 devices: scrapped by stryker.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed or reused.
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 (b)(6) 2026.This report summarizes 2 events for the failure: detachment of device or device component.- 2 events 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.Mfr report # 3015967359-2026-99195.Supplemental rationale.Corrected data: b5, h1, h6, h11.2 events were originally reported for this failure mode during the reporting quarter; however, - 1 event was inadvertently excluded.- 3 reported events are included in this follow-up record.Product return status 3 devices were received.Evaluation findings (results/components).1 device: wear problem / housing.1 device: no device problem found / part/component/sub-assembly term not applicable.1 device: wear problem / housing, spring.Product disposition.3 devices: scrapped by stryker.
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 january 1 ¿ march 31 2026.This report summarizes 3 events for the failure: detachment of device or device component.- 1 event had problem identified before clinical use/exposure; there was no patient involvement.- 2 events had problem identified during non-clinical procedure; there was no patient involvement.

• Brand Name: MD SERIES LONG STRAIGHT ATTACHMENT
• Common Device Name: UNIT, OPERATIVE DENTAL
• 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: 24953797
• Report Number: 3015967359-2026-99195
• Device Sequence Number: 10029650
• Product Code: EIA
• UDI-Device Identifier: 04546540380289
• UDI-Public: 04546540380289
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 5100015270
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 04/28/2026
• 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