MAUDE Adverse Event Report: STRYKER GMBH THREADED GUIDE WIRE ASNIS III Ø1.4X150MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702459S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
As reported: "the guide pin: (702459s) broke during drilling with a hollow drill, and the tip of the cannulated drill (702449) became distorted.As a result, the cannulated drill (702449) became stuck in the drill sleeve (702465).The broken pieces were removed from patient bone without any particular difficulty, and the procedure was resumed using new devices.There was no impact on the patient.".
Additional Manufacturer Narrative
Please note the correction to d9 as the device was returned for evaluation.The reported event could be confirmed, since the guide wire is broken and the drill bit cannot be removed from the drill guide as described in the event description.The device inspection revealed the following: the reported devices were returned for evaluation, the drill bit cannot be removed from the drill guide but it otherwise freely movable back and forth.It is visible that the cutting flutes of the drill bit are expanded at the forefront and therefore it is not possible to remove the drill from the drill guide.The guide wire is sheared off and completely stuck on a depth of about 2mm in the drill bit, a closer inspection of the guide wire is therefore not possible.The remainder of the guide wire was not returned for evaluation.The microscopic inspection has shown that the corners of the cutting edges are completely rounded at the forefront.This damage is a clear indication for an excessive metallic contact at the outside of the drill bit during drilling.In addition there are stress marks at the inside visible, which shows that there was also an excessive metallic contact at the inside by the guide wire.These contacts have led to the expansion of the cutting edges with small cracks between the grooves.The rounded appearance of the fracture face shows that the wire was sheared off as it could not withstand the applied force.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 user related issue.The event was most likely caused by an excessive metallic contact with an already placed screw or wire.Due to this contact the drill bit did change his direction and the guide wire did get bent by this, finally the pressure on the guide wire was that high the first the tip of the drill bit was expanded and the wire itself was sheared off by the drill bit.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the guide pin (702459s) broke during drilling with a hollow drill, and the tip of the cannulated drill (702449) became distorted.As a result, the cannulated drill (702449) became stuck in the drill sleeve (702465).The broken pieces were removed from patient bone without any particular difficulty, and the procedure was resumed using new devices.There was no impact on the patient.".

• Brand Name: THREADED GUIDE WIRE ASNIS III Ø1.4X150MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21883844
• Report Number: 0008031020-2025-00744
• Device Sequence Number: 3442707
• Product Code: LXH
• UDI-Device Identifier: 04546540381996
• UDI-Public: (01)04546540381996(17)291031(10)8648AA
• 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): 07/08/2025

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: 702459S
• Device Lot Number: 8648AA
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female