MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.0MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820103010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a surgical procedure, a wire pass drill broke at the tip.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6; the reported event, for breakage, was not confirmed as the device was not returned for evaluation.Without the device, the root cause cannot be determined.H3 other text : device not received by stryker.
Event or Problem Description
It was reported that during a surgical procedure, a wire pass drill broke at the tip.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 1.0MM WIRE PASS DRILL BIT
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9483240
• Report Number: 0001811755-2019-04082
• Device Sequence Number: 258605
• Product Code: HBE
• UDI-Device Identifier: 04546540362407
• UDI-Public: 04546540362407
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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: 08/01/2022
• Device Model Number: 5820103010
• Device Catalogue Number: 5820103010
• Device Lot Number: 19224017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1