MAUDE Adverse Event Report: STRYKER GMBH TWIST DRILL, DIAM.1.4X94MM, WL 27MM, WITH STOP, STRYKER SHAFT; BIT, DRILL

Model Number	60-14126
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
As reported: "1 twist drill broken".
Additional Manufacturer Narrative
Correction: refer to d4 lot number the reported event could be confirmed, since the image of the broken drill was provided and matches the alleged failure mode.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number communicated was not correct due to which the corresponding file could not be traced in the records.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿in the rare event of twist drill failure, drill guides serve to protect the user, patient, and other third parties.When testing twist drills in free air prior to surgical use, it is recommended to use the lowest possible rotational speed.This enables the user to more easily assess concentricity and proper direction of rotation.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, in general few of the probable causes of twist drill breakage are wrong speed for drilling, no axial guidance (torsional bending breakage) etc.If the device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "1 twist drill broken".

• Brand Name: TWIST DRILL, DIAM.1.4X94MM, WL 27MM, WITH STOP, STRYKER SHAFT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10338829
• Report Number: 0008031020-2020-01987
• Device Sequence Number: 14247522
• Product Code: HTW
• UDI-Device Identifier: 04546540246684
• UDI-Public: 04546540246684
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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 Model Number: 60-14126
• Device Catalogue Number: 60-14126
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1