MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 DUAL TRIGGER WIRE COLLET; WIRE-DRIVING POWER TOOL ATTACHMENT

Model Number	7203026000
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during equipment testing conducted by a manufacturer field service technician at the user facility paint chipped on the device.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
Confirmed; possible cleaning practices or improper use/handling.
Event or Problem Description
It was reported that during equipment testing conducted by a manufacturer field service technician at the user facility paint chipped on the device.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: SYSTEM 7 DUAL TRIGGER WIRE COLLET
• Common Device Name: WIRE-DRIVING POWER TOOL ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9954940
• Report Number: 0001811755-2020-00903
• Device Sequence Number: 16847681
• Product Code: HWE
• UDI-Device Identifier: 04546540640161
• UDI-Public: 04546540640161
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: Other
• Device Model Number: 7203026000
• Device Catalogue Number: 7203026000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 03/21/2020
• Supplement Date Received by Manufacturer: 03/21/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1