MAUDE Adverse Event Report: STRYKER GMBH ADVANCED LOCKING SCREW IMN SCREWS Ø5X32.5MM; SCREW, FIXATION, BONE

Catalog Number	23615032S
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Advanced locking screw got stuck when surgeon started to engage the contralateral cortex.The screw head worn and could not be extracted.The patient had no impact.
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 in a supplemental report.
Additional Manufacturer Narrative
Correction - please refer to h6 component code.The reported event could be confirmed on provided x-ray.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.A received x-rays copy showed a proximal locking screw not being completely inserted in the static mode.It had become stuck when the wider screw diameter engaged into the nail¿s thread.The distal screw was placed as intended.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.The op- tech instructs - to confirm correct starting point and axial alignment of the screw, gently rotate the screw counter-clockwise while applying gentle axial force.A click sound or snapping of the thread indicates that the screw is in the correct position.Once position has been confirmed, insert the screw by rotating clockwise until the screw is fully seated.Carefully observe the nail position during advanced locking screw insertion using x-ray.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented a 70-year-old female patient had been treated with a gamma4 nail using above advanced locking screw.It was reported >an advanced locking screw was used for the lateral screw holes, but the screw got stuck when it started to engage the contralateral cortex.The screw head worn and could not be extracted.The wound was closed as it is.The x-ray was forwarded to a consulting hcp for review.His opinion was to leave the screw as is.He did not expect significant irritation of the tissue.With available information it was suggested that the advanced locking screw had been inserted under misalignment with powerful forces.The treads had seized at the transition to wider diameter.With available information the root cause was regarded being user related.With available information a product deficiency was not verified.
Event or Problem Description
Advanced locking screw got stuck when surgeon started to engage the contralateral cortex.The screw head worn and could not be extracted.The patient had no impact.

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X32.5MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 19703142
• Report Number: 0009610622-2024-00424
• Device Sequence Number: 7720514
• Product Code: HWC
• UDI-Device Identifier: 07613327381566
• UDI-Public: 07613327381566
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: 23615032S
• Device Lot Number: K187D32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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 Age: 70 YR
• Patient Sex: Female