MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 ASEPTIC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	6126120000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2020
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 device investigation types have not yet been determined.2 devices were not labeled for single-use.2 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device fractured.1 event had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 2 malfunction events in which the device or cutting accessory fractured.Event had no patient involvement; no patient impact.1 event had 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 corrected data: b5, h10.2 previously reported events are included in this follow-up record.Product return status 2 devices were received.Event confirmation status 2 reported events were confirmed.Evaluation results 2 devices were found to be affected by a fractured hinge.

• Brand Name: SYSTEM 6 ASEPTIC HOUSING
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10330245
• Report Number: 0001811755-2020-01928
• Device Sequence Number: 14346165
• Product Code: HWE
• UDI-Device Identifier: 04546540501578
• UDI-Public: 04546540501578
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• 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): 10/30/2020

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
• Operator of Device: No Information
• Device Model Number: 6126120000
• Device Catalogue Number: 6126120000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1