MAUDE Adverse Event Report: STRYKER GMBH U-BLADE SET, TI GAMMA3® Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30660090S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the gamma3 u-blade lag screw was implanted in the left femur in 2017.Because the patient had not visited the hospital after discharge, the follow-up medical examination was not performed.On (b)(6) 2023, the patient visited the outpatient department of the hospital, and cutout of the lag screw and broken of the u-blade were confirmed.The ct examination revealed that the part of the broken u-blade was left in the pelvis.The revision surgery was performed".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the gamma3 u-blade lag screw was implanted in the left femur in 2017.Because the patient had not visited the hospital after discharge, the follow-up medical examination was not performed.On (b)(6) 2023, the patient visited the outpatient department of the hospital, and cutout of the lag screw and broken of the u-blade were confirmed.The ct examination revealed that the part of the broken u-blade was left in the pelvis.The revision surgery was performed".
Additional Manufacturer Narrative
Please note the correction to d4 lot #.The reported event could be confirmed, since the device was returned and matched the alleged issue.The device inspection revealed the following: the received u-blade lag screw showed normal signs of usage, however, one of the legs of the u-blade was found to be broken.The fracture surface shows typical signs of fatigue failure evident by appearance of lines of rest originating from one of the corners.A functional inspection was performed with the broken u-blade.The u-blade could be inserted properly without any deviation or misalignment.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, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation and the fact that the implant was inside patient for about 6 years, it can be ascertained that the u-blade broke in a fatigue manner, most likely due to constant overloading over a long period of time.If any further information is provided, the complaint report will be updated.

• Brand Name: U-BLADE SET, TI GAMMA3® Ø10.5X90MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17548911
• Report Number: 0009610622-2023-00280
• Device Sequence Number: 15124304
• Product Code: HSB
• UDI-Device Identifier: 04546540595980
• UDI-Public: 04546540595980
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/12/2023

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: 12/31/2020
• Device Catalogue Number: 30660090S
• Device Lot Number: K07DEDA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female