MAUDE Adverse Event Report: STRYKER GMBH ADVANCED LOCKING SCREW IMN SCREWS Ø5X65MM; SCREW, FIXATION, BONE

Model Number	2361-5065S
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
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
As reported: advanced locking screw cross threaded into oblique hole.Screw would not advance (or back out) with power or hand to the point of stripping the screw.Eventually was able to put on short capture screwdriver to barely remove screw.Replaced with a standard locking screw.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned, and no additional information was available.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "advanced locking screw cross threaded into oblique hole.Screw would not advance (or back out) with power or hand to the point of stripping the screw.Eventually was able to put on short capture screwdriver to barely remove screw.Replaced with a standard locking screw.".
Event or Problem Description
As reported: "advanced locking screw cross threaded into oblique hole.Screw would not advance (or back out) with power or hand to the point of stripping the screw.Eventually was able to put on short capture screwdriver to barely remove screw.Replaced with a standard locking screw.".

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X65MM
• 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: 15335673
• Report Number: 0009610622-2022-00405
• Device Sequence Number: 6478063
• Product Code: HWC
• UDI-Device Identifier: 07613327381634
• UDI-Public: 07613327381634
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/23/2023

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: 2361-5065S
• Device Catalogue Number: 23615065S
• Device Lot Number: K019BAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 11/23/2022; 09/28/2023
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 12/21/2022; 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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: Male