MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SYSTEM 7 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	7208000000
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
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 8 events were reported for this quarter.Product return status 6 devices were received.2 devices were not available for evaluation.Additional information 8 devices were not labeled for single-use.8 devices were reprocessed or reused.
Event or Problem Description
This report summarizes 8 malfunction events in which the device had run-on.7 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 8 malfunction events in which the device had run-on.7 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
Additional Manufacturer Narrative
Additional information: 8 devices were 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.Supplemental rationale corrected data: h10.(b)(4) previously reported events are included in this follow-up record.Product return status (b)(4) devices were received.(b)(4) device was not available for evaluation.
Event or Problem Description
This report summarizes 8 malfunction events in which the device had run-on.(b)(4) events had no patient involvement; no patient impact.(b)(4) event had patient involvement; no patient impact.

• Brand Name: SYSTEM 7 SAGITTAL SAW
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 15666676
• Report Number: 3015967359-2022-02142
• Device Sequence Number: 2724651
• Product Code: HWE
• UDI-Device Identifier: 07613252251033
• UDI-Public: 07613252251033
• 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): 07/27/2023

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 Model Number: 7208000000
• Device Catalogue Number: 7208000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 09/30/2022; 09/30/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 01/30/2023; 07/27/2023
• 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