MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO T2 Ø4,2X340 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18064260
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the drill made contact with the nail during drilling and broke off.".
Additional Manufacturer Narrative
Please note the correction to d4 gtin.The reported condition could be confirmed as the drill bit was returned broken.The device inspection revealed the following: as received condition the device is broken off at the crossover to the shaft and the drill bit.Both fragments were returned for evaluation.The breakage surface reveals typical characteristics of a brittle fracture (relatively smoother surface at the center than at the edges without any plastic deformation).In addition, small nicks and dents at the cutting flutes can be observed, confirming the reported contact between the drill and the nail.Therefore, the appearance of the fracture zone shows that mechanical overload by applying excessive torsional force, most likely caused by metallic contact with the nail, did lead to the breakage of the drill bit.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 be user related.The appearance of the fracture zone shows that a mechanical overload by applying excessive torsional force, most likely caused by metallic contact with the nail, did lead to the breakage of the drill bit.As a reminder, the instructions for use state the following: « avoid drilling into metal implants with bone drills.The implants could be critically weakened and break under load and the drill could be damaged.» if more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the drill made contact with the nail during drilling and broke off.".

• Brand Name: DRILL, AO T2 Ø4,2X340 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21470245
• Report Number: 0008031020-2025-00358
• Device Sequence Number: 11615443
• Product Code: LXH
• UDI-Device Identifier: 04546540196767
• UDI-Public: (01)04546540196767(17)280831(10)K1776A3
• 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): 04/29/2025

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: 18064260
• Device Lot Number: KU166947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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 Sex: Female