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	11/08/2023
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
As reported: "orif was performed for right humeral shaft fracture on november 8, 2023.When drilling into the hole of the nail, the drill contacted with the nail and advanced without getting into the hole of the nail, resulting in fracture of the drill tip.The drill tip was stuck in the bone, but was removed by grasping it with pliers.The doctor told that unintended contact of the drill with the k-wire just before the drill was inserted into the nail hole might affect the reported fracture of the drill tip.".
Additional Manufacturer Narrative
The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned drill was confirmed based on the catalog # and the lot # marked.The reported event could be confirmed, as the drill is broken into two parts.Both parts were returned.Damage and wear could be observed on the tip of the drill.This damage is a direct result of the reported misaligned drilling.Microscopic images give evidence of a sudden brittle fracture, as indicated by the smooth homogeneous surface of breakage.The fracture origination could be observed at the part of the tip with the most damage.This is precisely the part that went in contact against the nail first, where the device was weakened.Dimensional and material integrity inspection showed the device to be according to specification.Based on investigation, the root cause was attributed to an user related issue.The failure was caused by careless usage of the device.Misaligned drilling cause the drill to be in contact with the nail, which weakened it and ultimately led to the breakage when drilling into the bone.As a reminder, the instructions for use clearly state that: " avoid drilling into metal implants with bone drills.The implants could be critically weakened and break under load and the drill could be damaged." 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 more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "orif was performed for right humeral shaft fracture on (b)(6) 2023.When drilling into the hole of the nail, the drill contacted with the nail and advanced without getting into the hole of the nail, resulting in fracture of the drill tip.The drill tip was stuck in the bone, but was removed by grasping it with pliers.The doctor told that unintended contact of the drill with the k-wire just before the drill was inserted into the nail hole might affect the reported fracture of the drill tip.".

• 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: 18240012
• Report Number: 0009610622-2023-00433
• Device Sequence Number: 3305898
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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: KU116661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2019
• 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: 32 YR
• Patient Sex: Male