MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT Ø2.0MM X 122MM AO FITTING FOR 2.7MM SCREW; SCREW, FIXATION, BONE

Catalog Number	703701
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
Customer reported to sales rep that: "the drill broke during intervention".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.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.A review of the device history for the reported lot did not reveal any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition unknown.
Event or Problem Description
Customer reported to sales rep that: "the drill broke during intervention".

• Brand Name: DRILL BIT Ø2.0MM X 122MM AO FITTING FOR 2.7MM SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8798928
• Report Number: 0008031020-2019-00832
• Device Sequence Number: 13533036
• Product Code: HWC
• UDI-Device Identifier: 07613154973422
• UDI-Public: 07613154973422
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: Health Professional
• Device Catalogue Number: 703701
• Device Lot Number: 15530Y
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1