MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.5MM FINE DIAMOND ROUND EXTENDED; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5540011315
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not returned to manufacturer for evaluation.
Event or Problem Description
It was reported that during an ent procedure, the bur broke along the shaft.It was also reported that there was a minor delay to search for the bur in the patient, no device fragments were located.It was further reported that there were no adverse consequences and the procedure was completed successfully.
Event or Problem Description
It was reported that during an ent procedure, the bur broke along the shaft.It was also reported that there was a minor delay to search for the bur in the patient, no device fragments were located.It was further reported that there were no adverse consequences and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: 1.5MM FINE DIAMOND ROUND EXTENDED
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10425106
• Report Number: 0001811755-2020-02194
• Device Sequence Number: 14080548
• Product Code: HBE
• UDI-Device Identifier: 04546540700599
• UDI-Public: 04546540700599
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K032303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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: Health Professional
• Device Expiration Date: 11/01/2024
• Device Model Number: 5540011315
• Device Catalogue Number: 5540011315
• Device Lot Number: 19325017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1