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

Catalog Number	703701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
During a osteosynthesis surgery of the right humerous, 2.0 mm cutter ref.703701 broke, in the tray there were 2 items of the same code with the respective lots 04470v- 04830v (customer cannot say which is the lot nr.).Part of the device remained in the body.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be fatigue related.The failure was caused by the fatigue of the material, which is highly connected to the normal wear of the device, since it has been used since 2017.Furthermore, the use of the instrument on a patient with hard bone could also have accelerated the breakage, since the mechanical forces to which it had been subjected are high.The device inspection revealed the following: the microscope picture of the broken tip of the device shows shiny areas, which are the indicator that the material broke mainly because of fatigue.Indeed, the shiny spots indicate that the device first of all broke partially, and that the two parts rubbed against each other before breaking completely.This behavior is characteristic of a fatigue fracture.Moreover, the breakage lines further prove that the material underwent torsion, which is logical with the use of the device.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 any further information is provided, the investigation report will be updated.
Event or Problem Description
During a osteosynthesis surgery of the right humerous, 2.0 mm cutter ref.703701 broke, in the tray there were 2 items of the same code with the respective lots 04470v- 04830v (customer cannot say which is the lot nr.) part of the device remained in the body.

• Brand Name: DRILL BIT Ø2.0MM X 122MM AO FITTING FOR 2.7MM SCREW
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8487662
• Report Number: 0008031020-2019-00349
• Device Sequence Number: 19145904
• Product Code: HRS
• UDI-Device Identifier: 07613154973422
• UDI-Public: 07613154973422
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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: 04470V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other