MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.5MM PRCSN MTCH HD EXT, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	8450-107-525L
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during an mis laminectomy procedure, the bur broke along the shaft.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not returned.
Event or Problem Description
It was reported that during an mis laminectomy procedure, the bur broke along the shaft.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 2.5MM PRCSN MTCH HD EXT, 13CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10922979
• Report Number: 0001811755-2020-03299
• Device Sequence Number: 13810182
• Product Code: HBE
• UDI-Device Identifier: 07613327402254
• UDI-Public: 07613327402254
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K143540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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 Expiration Date: 02/01/2023
• Device Model Number: 8450-107-525L
• Device Catalogue Number: 8450107525L
• Device Lot Number: 20035027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5407120900 SN (B)(6); 5407120950A SN (B)(6); 5407120900 SN1936110253; 5407120950A SN1834531053