MAUDE Adverse Event Report: STRYKER GMBH SET SCREW GT T2 ALPHA FEMUR ANTEGRADE Ø8; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23310000S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Perforation (2001); Hip Fracture (2349)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device discarded.
Event or Problem Description
As reported: "t2alphagt was used in the recom mode on (b)(6) 2023 for a subtrochanteric fracture of the femur.After surgery, dr confirmed cutout by both lag screws at femoral head when postoperative follow-up.Removal surgery was done at (b)(6) 2023.The dr felt that the set screws seemed to be loosely fastened to the lag screws during removal surgery.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "t2alphagt was used in the recom mode on (b)(6) 2023 for a subtrochanteric fracture of the femur.After surgery, dr confirmed cutout by both lag screws at femoral head when postoperative follow-up.Removal surgery was done at (b)(6) 2023.The dr felt that the set screws seemed to be loosely fastened to the lag screws during removal surgery.".

• Brand Name: SET SCREW GT T2 ALPHA FEMUR ANTEGRADE Ø8
• 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: 17714467
• Report Number: 0009610622-2023-00305
• Device Sequence Number: 12508057
• Product Code: HSB
• UDI-Device Identifier: 07613327343113
• UDI-Public: 07613327343113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• 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): 11/03/2023

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 Catalogue Number: 23310000S
• Device Lot Number: K06A864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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 Sex: Female