MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO HUDSON/MODIFIED TRINKLE ATTACHMENT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	6203135000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2019
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: 12 events were reported for this quarter.Product return status: 12 device investigation types have not yet been determined.Additional information: 12 devices were not labeled for single-use.12 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 12 malfunction events in which the device was reportedly leaking.12 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 corrected data: h10 12 previously reported events are included in this follow-up record.Product return status 11 devices were not available for evaluation.1 device investigation type has not yet been determined.
Event or Problem Description
This report summarizes 12 malfunction events in which the device was reportedly leaking.12 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 corrected data: b5, h10 12 previously reported events are included in this follow-up record.Product return status 1 device was received.11 devices were not available for evaluation.Event confirmation status 1 reported event was not confirmed.Evaluation results 1 device had no problem found.
Event or Problem Description
This report summarizes 12 malfunction events in which the device was reportedly leaking.12 events had no patient involvement; no patient impact.

• Brand Name: HUDSON/MODIFIED TRINKLE ATTACHMENT
• 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: 9637297
• Report Number: 0001811755-2020-00335
• Device Sequence Number: 2784141
• Product Code: HWE
• UDI-Device Identifier: 04546540501684
• UDI-Public: 04546540501684
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 12
• 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): 10/29/2020

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: 6203135000
• Device Catalogue Number: 6203135000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 12/31/2019
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 04/29/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1