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

Catalog Number	2296301000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events - 15 events were reported for this quarter.Product return status - 15 devices were available for evaluation but have not yet been received.Additional information - 15 devices were not labeled for single-use.15 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 15 malfunction events in which the device fractured.15 events had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 15 malfunction events in which the device fractured.15 events had patient involvement; no patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale corrected data: 15 total events were initially reported.15 previously reported events are included in this follow-up record.  product return status 15 devices were not available for evaluation.Additional information 15 devices were labeled for single-use.15 devices were not reprocessed and reused.

• Brand Name: IMPACTION BUR GUARD
• 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: 8014397
• Report Number: 0001811755-2018-01976
• Device Sequence Number: 1395934
• Product Code: ERL
• UDI-Device Identifier: 04546540046765
• UDI-Public: 04546540046765
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 15
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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 Catalogue Number: 2296301000
• Device Lot Number: E2015055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2018
• Supplement Date Received by Manufacturer: 06/02/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1