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

Model Number	705031
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
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
As reported: "during an intervention for a complex fracture of proximal humerus: two drill bits d.2.5 broken during the perforation of the humeral shaft, through a hole in the plate.Broken distal part recovered.A drill bit d.3,1, broken during the perforation of the humeral head, through a hole in the plate.Broken distal part recovered.".
Event or Problem Description
As reported: "during an intervention for a complex fracture of proximal humerus: two drill bits d.2.5 broken during the perforation of the humeral shaft, through a hole in the plate.Broken distal part recovered.A drill bit d.3,1, broken during the perforation of the humeral head, through a hole in the plate.Broken distal part recovered.".
Additional Manufacturer Narrative
Correction: refer to d10/h3 the reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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.If any additional information is provided, the investigation will be reassessed.Device disposition is unknown.

• 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: 9788689
• Report Number: 0008031020-2020-00574
• Device Sequence Number: 714476
• Product Code: HWE
• UDI-Device Identifier: 07613327083316
• UDI-Public: 07613327083316
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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: 705031
• Device Catalogue Number: 705031
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR