MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADVANCED LOCKING SCREW IMN SCREWS Ø5X37.5MM; SCREW, FIXATION, BONE

Model Number	2361-5037S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
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 in a supplemental report.
Event or Problem Description
It was reported that when the advanced locking screw was inserted to t2 alpha gt nail, it got stuck and could be neither advanced nor pulled out.Attempts were made to extract the screw, but the head was worn out and could no longer be extracted.As a result, the head was cut off and the surgery was completed.This resulted in extended operating time.
Event or Problem Description
It was reported that when the advanced locking screw was inserted to t2 alpha gt nail, it got stuck and could be neither advanced nor pulled out.Attempts were made to extract the screw, but the head was worn out and could no longer be extracted.As a result, the head was cut off and the surgery was completed.This resulted in extended operating time.
Additional Manufacturer Narrative
Please note corrections to h3 and h6 method code.The reported event could be confirmed, although the device was not returned for evaluation but a couple of x-rays were shared which confirms the alleged failure.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.A formal medical opinion was sought from our medical expert regarding the potential harm that may be there leaving the screw in such a manner, to which he replied "usually there is not a huge harm for the patient when the screw is places in such a manner.It will be challenging if there is a need to remove the nail at a later stage, though." [original statement].Regarding the event and the questions asked by the customer, a technical opinion was requested from the r&d, to which the below assessment was received which basically indicates towards following the operative technique."if constraints during screw insertion create high torque, the screw should be removed and the preparation steps for the als screw according to the operative technique should be followed/ repeated: countersinking of lateral cortex, manual reaming up to the nail, if the hole is in the area of spongious bone, and most importantly: the screw should pass through the sleeve until the larger thread portion reaches the nail.Then counterclockwise turning should result in a ¿click¿ signal of the threads in order to make sure that the screw thread synchronizes with the nail.The screw should not create high torque during insertion.If an als screw is inserted with freehand locking, the thread interface works in a cone of 18° angle.In case of guided locking there is no angular mismatch.It is the same with regular locking screws.If a nail is already constrained by other screws, you may encounter high torque.In that case, screw removal and drill path correction is advised." [original statements].Based on the above investigation, the root cause of the issue is user related.Improper passage preparation for the screw is the most likely cause of the failure.Operative technique must be followed at all times during the course of any surgery.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X37.5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 15904030
• Report Number: 0009610622-2022-00565
• Device Sequence Number: 17583161
• Product Code: HWC
• UDI-Device Identifier: 07613327381702
• UDI-Public: 07613327381702
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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 Model Number: 2361-5037S
• Device Catalogue Number: 23615037S
• Device Lot Number: K07E260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2022
• 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: 75 YR
• Patient Sex: Female