MAUDE Adverse Event Report: STRYKER TRAUMA KIEL U-BLADE SET, TI GAMMA3 10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3066-0090S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Foreign Body In Patient (2687)
Date of Event	11/30/2020
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: "the customer implanted a gamma3 nail with a u-blade shs in a patient.This (u-blade) is broken in the patient.After the surgeon has removed the nail again, the patient requests an examination of the implant." additional information received through the x-rays: the lag screw of the u-blade set is broken in the patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: from technical point the received u-blade lag screw was found to be broken from approximately second winding from the base.External sem examination identified typical signs of a fatigue fracture.The incipient crack had its origin in the transition from minor diameter to the thread flank.From medical point of view and with available information no safe conclusion was possible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The above investigation confirms the breakage of the lag screw in a fatigue manner, with the fracture initiating from one of the windings.However, the real root cause for the initiation of the fracture could not be determined.An non conformity report for the further evaluation of the breakage has been initiated.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "the customer implanted a gamma3 nail with a u-blade shs in a patient.This (u-blade) is broken in the patient.After the surgeon has removed the nail again, the patient requests an examination of the implant." additional information received through the x-rays: the lag screw of the u-blade set is broken in the patient.

• Brand Name: U-BLADE SET, TI GAMMA3 10.5X90MM
• 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: 11069934
• Report Number: 0009610622-2020-01044
• Device Sequence Number: 3207200
• Product Code: HSB
• UDI-Device Identifier: 04546540595980
• UDI-Public: 04546540595980
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• 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
• Report Date (Section B): 03/22/2021

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: Lay User/Patient
• Device Expiration Date: 10/31/2024
• Device Model Number: 3066-0090S
• Device Catalogue Number: 30660090S
• Device Lot Number: K084003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/22/2021
• 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: Required Intervention