MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L50MM; PLATE, FIXATION, BONE

Model Number	661050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "screw breakage in axsos 3 distal medial plate described by customer as cold welding.Proximal locking screw measured too long, when going to change the screw out the screw head broke.The locking tower was used correctly, the torque wrench was used to tighten the screw initially.Initial removal was attempted on hand screwdriver.A broken screw removal set was used to remove the broken screw from the lateral side, to do this a burr was used to remove a portion of a fibula plate which had been placed in the same operation.2 screw driver shafts were broken in the procedure.".

• Brand Name: LOCKING SCREW AXSOS 3 TI 4.0MM / L50MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11577611
• Report Number: 0008031020-2021-00110
• Device Sequence Number: 3521324
• Product Code: HRS
• UDI-Device Identifier: 07613252579908
• UDI-Public: 07613252579908
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 661050
• Device Catalogue Number: 661050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1