MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, TRI-FLAT T2 HUMERUS Ø3,5X230 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	1806-3545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
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
During the upper arm operation, when the proximal drill whole was attempted to create, the tip part of the drill was broken.The broken piece was left inside the body once, but it was able to take out safely using a device.The procedure completed successfully using the replaced drill.The surgeon¿s opinion: the patient¿s bone quality was so hard that it couldn¿t be helped.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the received drill was broken into two near the region from where the flutes start.Several deformation and dents along the flutes edges are visible indicating towards an intense usage.However, the breakage pattern reveals signs (relatively smooth surface) of a typical brittle fracture due to bending overload.A few stains on the breakage surface are also visible which appear similar to blood residues that couldn¿t be cleaned.This is however unrelated to the event.A dimensional inspection of the flutes were performed and the observed dimensions (core dia: 3.48mm ) were well within the range of required dimension (core dia: 3.4mm to 3.5mm).This is the first reported case with this lot number.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause was attributed to a user related issue.The drill broke in a brittle manner due to a bending overload in order to penetrate through the hard bone (as suggested by the event).It has been determined this is the reason why the drill broke from the distal part of the shaft.Also, it must be noted that as the op-tech suggests, it was advisable to use the centre-tipped drill but instead a tri-flat drill was used.If any further information is provided, the complaint report will be updated.
Event or Problem Description
During the upper arm operation, when the proximal drill whole was attempted to create, the tip part of the drill was broken.The broken piece was left inside the body once, but it was able to take out safely using a device.The procedure completed successfully using the replaced drill.The surgeon¿s opinion: the patient¿s bone quality was so hard that it couldn¿t be helped.

• Brand Name: DRILL, TRI-FLAT T2 HUMERUS Ø3,5X230 MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9345722
• Report Number: 0009610622-2019-00930
• Device Sequence Number: 382219
• Product Code: HWE
• UDI-Device Identifier: 04546540196620
• UDI-Public: 04546540196620
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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: 1806-3545
• Device Catalogue Number: 18063545
• Device Lot Number: KU107270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR