MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORATOR CHUCK; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	5400210060
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported three metal objects were observed in the patient's skull during a post-op scan following a procedure in which the device had been in use.The user facility reported a revision procedure was performed and 2 of the 3 metal objects were successfully retrieved.One object remains in place.There was no allegation of device failure during the initial procedure.No additional adverse consequences have been reported.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
The user facility reported three metal objects were observed in the patient's skull during a post-op scan following a procedure in which the device had been in use.The user facility reported a revision procedure was performed and 2 of the 3 metal objects were successfully retrieved.One object remains in place.There was no allegation of device failure during the initial procedure.No additional adverse consequences have been reported.

• Brand Name: PERFORATOR CHUCK
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8946471
• Report Number: 0001811755-2019-02869
• Device Sequence Number: 14105760
• Product Code: HBB
• UDI-Device Identifier: 04546540074515
• UDI-Public: 04546540074515
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: 041754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5400210060
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1