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

Catalog Number	18063540
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: while drilling, the drill bit broke.Additionally, it was reported, all the debris were removed from the surgical field, patient.
Event or Problem Description
As reported: while drilling, the drill bit broke.Additionally, it was reported, all the debris were removed from the surgical field/patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the drill bit is broken as complained.The device inspection revealed the following: the visual inspection has shown that the drill bit is broken at the crossover from the cutting flutes to the shaft.The breakage is clean without fragmentation.The tip is worn at the forefront and the cutting edges are blunt in this area.Also the cutting edges at the flutes are damaged.There are many nicks visible, most likely caused by metallic contacts with the nail over the years as the device was manufactured in the year 2019.The microscopic inspection of the fracture face has shown that the view is typical for a brittle overload fracture with a shear lip on one side.The shear lip indicates that the device was exposed to high lateral forces when it broke.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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.Based on investigation, the root cause was attributed to a used related issue.Based on the appearance of the received drill bit did most likely a combination between too much lateral stress, increased resistance due to the blunt cutting edges to a mechanical overload.In this relation following statement of the t2 instruments instructions for use can be pointed out: "ensure that the drilling and cutting tools to be used are sharp; discard them if they are not." if more information is provided, the case will be reassessed.

• Brand Name: DRILL, AO T2 HUMERUS Ø3,5X230 MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18727688
• Report Number: 0009610622-2024-00075
• Device Sequence Number: 20268977
• Product Code: HWE
• UDI-Device Identifier: 04546540196606
• UDI-Public: 04546540196606
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/15/2024

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: 18063540
• Device Lot Number: KU109235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female