MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X70MM TL23.5MM; SCREW, FIXATION, BONE

Catalog Number	325070
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
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.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that during another one of these cases with another 4.0 stainless screw, it started to unthread once again.A screw that began unthreading was implanted into the patient but the doctor decided to leave it in as it didn't come completely unthreaded, only the tip.The surgeon decided to leave the screw implanted in the patient.
Event or Problem Description
It was reported that during another one of these cases with another 4.0 stainless screw, it started to unthread once again.A screw that began unthreading was implanted into the patient but the doctor decided to leave it in as it didn¿t come completely unthreaded, only the tip.The surgeon decided to leave the screw implanted in the patient.
Additional Manufacturer Narrative
Please note the corrections to h6 results and h6 conclusion codes.The received x-rays were reviewed, and it can be confirmed that a fragment of the thread is detached from the screw.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Indications of material, manufacturing or design related problems were unable to be identified as the lot number was not communicated.A labelling review was performed and the following statement from the operative technique ¿asnis iii cannulates screw system (as-st-2, rev 2, 11-2016)¿ can be pointed out: ¿the self-cutting and self-tapping tip of the asnis 4.0mm screw is intended for cancellous bone.In dense cortical bone pre-drilling with the cannulated drill 2.7mm (702449) and use of the cannulated tap 4.0mm (702454) is recommended, especially when placing oblique screws¿.The case was discussed with medical affairs and rnd with the following result: the cutting function of the screw is at a 45 degree angle at the front of the screw.If the screw is inserted at an angle of more that 45 degrees, the cutting edge loses its function at one point.In the worst case, it may event hit the flat surface if the thread flank.This means that there is a strong load at this point when the screw hits the cortical bone, which can be especially in young patients quite strong.As a result, the load at this pint is very high without the presence of a cutting edge, which can ultimately lead to the tread peeling off.In this context, it can also be mentioned that the screws of the asnis iii system are cancellous bone screws, which are characterized by a relatively thin core and a wide and deep thread, whereby bi*cortical use is not necessarily intended.Therefore, the only way to avoid such an incident in this case is to use a tap.Based on investigation, the root cause attributed to a user related issue.The event was most likely caused by not using a tap as recommended int eh operative technique.If the device is returned, or if any additional information is provided, the investigation will be reassessed.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X70MM TL23.5MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20867524
• Report Number: 0008031020-2024-00637
• Device Sequence Number: 8592373
• Product Code: HWC
• UDI-Device Identifier: 07613327078060
• UDI-Public: 07613327078060
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K213199
• 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): 02/26/2025

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: 325070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 14 YR
• Patient Sex: Male