MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN AXSOS 3 4MM LOCKING SCREW; IMPLANT

Catalog Number UNK_SEL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device implanted in the patient.

Event Description

As reported: "after an axsos 3 humerus plate procedures, two distal locking screws diam.4mm came out the hole of the plate.".

Manufacturer Narrative

Please note the addition of the imdrf codes.

Event Description

As reported: "after an axsos 3 humerus plate procedures, two distal locking screws diam.4mm came out the hole of the plate.".

• Brand Name: UNKNOWN AXSOS 3 4MM LOCKING SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11495623
• MDR Text Key: 264482610
• Report Number: 0008031020-2021-00089
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1