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

Model Number	1900012000
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device remained activated after release during testing prior to a procedure. there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Event or Problem Description
The user facility reported that the device remained activated after release during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Additional information: d9 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-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 10754899
• Report Number: 0001811755-2020-02999
• Device Sequence Number: 1126412
• Product Code: HWE
• UDI-Device Identifier: 07613327071962
• UDI-Public: 07613327071962
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: E527860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: Health Professional
• Device Model Number: 1900012000
• Device Catalogue Number: 1900012000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1