MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3 10.5X105MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3066-0105S

Device Problems Positioning Failure (1158); Migration (4003)

Patient Problems Failure of Implant (1924); Perforation (2001)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "during lag screw did not slide, and it penetrated the femoral head.The surgeon it could be due to the set screw.".

Manufacturer Narrative

Correction: refer to b2, h6 device code.The alleged event could be reproduced based on the damage patters on the surfaces of the unbroken returned products.Review of device history, labelling, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No indications of material, manufacturing or design related problems were found during the document review.According to found surface pattern the event was initially caused by inappropriate placement of the set screw resulting in uncontrolled lag screw motion towards medial.The surgeon¿s opinion, event occurred due to the set screw, was confirmed.Inappropriate implant placement was regarded as user related.A product deficiency was not verified.In case essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.

Event Description

As reported: "during lag screw did not slide, and it penetrated the femoral head.The surgeon it could be due to the set screw.".

• Brand Name: U-BLADE SET, TI GAMMA3 10.5X105MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10348101
• MDR Text Key: 202881729
• Report Number: 0009610622-2020-00418
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540596017
• UDI-Public: 04546540596017
• Combination Product (y/n): N
• PMA/PMN Number: K043431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 3066-0105S
• Device Catalogue Number: 30660105S
• Device Lot Number: K060B87
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 87 YR