MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO T2 Ø3,5X130 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	18063550
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/24/2024
Type of Reportable Event	Serious Injury
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: "during humeral nailing, while passing through the oblong hole of the nail, the tip of the drill bit broke off and became stuck in the patient's bone, the piece of drill bit was left in place, removal would have been too disfiguring.There was no other consequences, the incident was isolated.The operation was delayed by around 20 minutes." 2/17/2024 - additional information received no other equipment was used to drill the bone apart from a skin incision and dissection to the distal humeral bone posteriorly.The drill scratched the distal nail hole (as usual), a trajectory correction was immediately undertaken, but the breaking sound had already occurred.It was then impossible to drill the 2nd cortex.On removing the drill, the distal break was discovered.
Event or Problem Description
As reported: "during humeral nailing, while passing through the oblong hole of the nail, the tip of the drill bit broke off and became stuck in the patient's bone, the piece of drill bit was left in place, removal would have been too disfiguring.There was no other consequences, the incident was isolated.The operation was delayed by around 20 minutes." 2/17/2024: additional information received: no other equipment was used to drill the bone apart from a skin incision and dissection to the distal humeral bone posteriorly.The drill scratched the distal nail hole (as usual), a trajectory correction was immediately undertaken, but the breaking sound had already occurred.It was then impossible to drill the 2nd cortex.On removing the drill, the distal break was discovered.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The received drill is broken from the tip and the broken fragment was not returned.Broken surface of the drill appears relatively smooth without showing any plastic deformation signs which indicates towards a brittle failure of the drill due to mechanical overload leading to sudden breakage.The device is in worn out condition which indicates that it has been extensively used over a long period of time.The edges are worn out and there are circular wear marks in the region proximal to the tip which indicates that an excess torsional force on a worn-out device has resulted in the breakage of drill.The outer diameter of the drill was found within specification.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with 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 the investigation, the root cause was attributed to be a user related.The event was caused due to application of excess torsional force on a worn-out device which was extensively used over a long period of time.If any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO T2 Ø3,5X130 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: 20993628
• Report Number: 0009610622-2024-00964
• Device Sequence Number: 8054007
• Product Code: HWE
• UDI-Device Identifier: 04546540196644
• UDI-Public: (01)04546540196644(11)151201(10)K059FCB
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 18063550
• Device Lot Number: KU59310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown