MAUDE Adverse Event Report: STRYKER GMBH CALIBRATED DRILL BIT Ø2.5MM X 285MM, AO; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	703586
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "drill bit breakage.Was there any debris reported? were they all removed from the surgical field/patient? some fragments were damaged, but all were recovered.Fragments were found but all have been recovered.How was the event resolved? when using two plates, the plate screws were struck and damaged.The damage has been removed and addressed.".
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the drill bit is broken as described in the event description.The device inspection revealed the following: the drill bit was returned for evaluation, and it can be confirmed that the drill bit broke apart at the crossover from the cutting flutes to the shaft.The broken fragment was not returned.In the shaft area of the drill proximal to breakage point, excessive stress marks are visible, also the cutting edges look slightly rounded and worn out on both sides of the flutes.During microscopic inspection, the typical view of a forced fracture, with no plastic deformation, a homogenous surface and a shear cavity on one side could be identified.Furthermore, a hardness test according to (b)(6) 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 investigation, the root cause was attributed to a user related issue.The event was most likely caused by a mechanical overload and worn-out cutting flutes from previous procedures may have played a certain role as well, since the drill bit was manufactured in the year 2020.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "drill bit breakage.Was there any debris reported? were they all removed from the surgical field/patient? some fragments were damaged, but all were recovered.Fragments were found but all have been recovered.How was the event resolved? when using two plates, the plate screws were struck and damaged.The damage has been removed and addressed.".

• Brand Name: CALIBRATED DRILL BIT Ø2.5MM X 285MM, AO
• 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 GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23633146
• Report Number: 0008031020-2025-02098
• Device Sequence Number: 9336741
• Product Code: HWE
• UDI-Device Identifier: 04546540694089
• UDI-Public: (01)04546540694089(11)200706(10)K0DDD63
• 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): 02/05/2026

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: 703586
• Device Lot Number: KU120291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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: 52 YR
• Patient Sex: Male