MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI LOCKING, SHORT, Ø3.1 X 216MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	705031S
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
As reported: "the sterile drill pack was carefully opened and the scrub nurse picked up the opposite end and went to open when he noticed the was a hole in the sterile paper lid.The external packaging wasn't damaged so the drill was still deemed sterile." procedure was completed successfully with "slight surgical delay" and no adverse consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed only based on the picture received.Based on investigation, the root cause was attributed to be user related.The failure was most probably caused by the mishandling of the product.The inner tyvek cannot be damaged by the device without mishandling of the packaging.In the area where the tyvek is damaged the device is protected by (b)(4).Therefore, this case is classified as a user related issue.A review of the device history for the reported lot did not indicate 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.
Event or Problem Description
As reported: "the sterile drill pack was carefully opened and the scrub nurse picked up the opposite end and went to open when he noticed the was a hole in the sterile paper lid.The external packaging wasn't damaged so the drill was still deemed sterile." procedure was completed successfully with "slight surgical delay" and no adverse consequences reported.

• Brand Name: DRILL BIT AXSOS 3 TI LOCKING, SHORT, Ø3.1 X 216MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9073051
• Report Number: 0008031020-2019-01279
• Device Sequence Number: 14370331
• Product Code: HWE
• UDI-Device Identifier: 07613327083330
• UDI-Public: 07613327083330
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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 Expiration Date: 04/30/2024
• Device Catalogue Number: 705031S
• Device Lot Number: 17175Y
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR