MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PISTOL BATTERY PACK; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	1900012000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer service technician reported that the device disassembled while it was being serviced at the user facility.There were no adverse consequences related to this event.
Event or Problem Description
The manufacturer service technician reported that the device disassembled while it was being serviced at the user facility.There were no adverse consequences related to this event.
Additional Manufacturer Narrative
Additional information: d10: device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: PISTOL BATTERY PACK
• 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: 9665940
• Report Number: 0001811755-2020-00387
• Device Sequence Number: 4245985
• Product Code: HWE
• UDI-Device Identifier: 07613327071962
• UDI-Public: 07613327071962
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: 1900012000
• Device Catalogue Number: 1900012000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1