MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X32MM TL11MM; SCREW, FIXATION, BONE

Catalog Number	325032S
Medical Device Problem Codes	Material Fragmentation (1261); Unraveled Material (1664); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "on (b)(6) 2024 an asnis screw of which the thread came loose.He was twisted into a metatarsal.Another k-wire crossed but we doubt if it was in the way.".
Event or Problem Description
As reported: "on 29.02.2024 an asnis screw of which the thread came loose.He was twisted into a metatarsal.Another k-wire crossed but we doubt if it was in the way." 26-mar-2024 - update.Patient involvement?: yes, but no permanent injury.Patient adverse consequences?: we were able to remove the screw was the procedure completed successfully?: we were able to remove the screw in its entirety and install a new one.
Additional Manufacturer Narrative
Please note correction to h6 (device code).The reported event could be confirmed based on the inspection performed.The identification of the returned cannulated screw was confirmed based on the catalog # and the lot # marked.The screw was returned stuck around the k-wire.It was not deemed necessary to disassemble the devices, since it would not have given any further information.It could be confirmed that the threads of the screw are completely unraveled, as reported.This is observed close to the bent part of the k-wire.There are no clear signs (such as scratches) that could indicate that the twisting results from the devices being in contact with another k-wire when inserting the screw.It was communicated that the patient suffers from diabetes and that the bone in question was soft, excluding bone hardness as the root cause of the deformation.This could be confirmed by the x-ray received.Note: it was not possible to determine with the x-ray if the devices crossed another k-wire during the insertion.Based on investigation, the root cause of the reported event was attributed to an user related issue.The deformation of the devices is most probably a result of excessive bending and/or torsional load applied during insertion.As a reminder, the instructions for use clearly state: "do not bend the asnis iii implant, because it may reduce its fatigue strength and can cause failure under load [.] while rare, intra-operative breakage of instruments can occur.Instruments which have experienced excessive use or excessive force are susceptible to breakage.Instruments should be examined for wear or damage prior to surgery." 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.If more information is provided, the case will be reassessed.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X32MM TL11MM
• 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: 18981335
• Report Number: 0008031020-2024-00143
• Device Sequence Number: 6213513
• Product Code: HWC
• UDI-Device Identifier: 07613327076042
• UDI-Public: 07613327076042
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: 325032S
• Device Lot Number: K63764
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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 Sex: Unknown