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

Model Number	3066-0105S
Medical Device Problem Codes	Positioning Failure (1158); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Perforation (2001)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem 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.".
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0009610622-2020-00418
• Device Sequence Number: 804090
• Product Code: HSB
• UDI-Device Identifier: 04546540596017
• UDI-Public: 04546540596017
• Combination Product (Y/N): N
• PMA/510(K) Number: K043431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 87 YR