MAUDE Adverse Event Report: STRYKER GMBH LAG SCREW, RECON T2 Ø6.5X90 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18976090S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Failure of Implant (1924); Unequal Limb Length (4534)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the surgery was performed on (b)(6), but the two proximal lag screws were inserted off the nail.The proximal bone fragment slid 7-8 cm distally, and the femur has shortened.Revision surgery was performed on (b)(6).".
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.Device disposition is unknown.
Additional Manufacturer Narrative
The reported event could be confirmed based on details available, only.As per labelling ¿to determine t2 lag screw recon placement prior to incising the skin, use of the one-shot device is recommended.The one-shot device is made of carbon fiber and works by providing a target to indicate the position of the k-wire on the fluoroscope screen¿¿ furthermore, it is pointed out ¿two aspects regarding the t2 alpha femoral nail / t2 lag screw recon position must be verified with the image intensifier prior to drilling into the femoral head: alignment of the anteversion (lateral view).Depth of nail insertion (anterior view).The inferior t2 lag screw recon should pass through the calcar region in the ap view and should be centered into the femoral head in the ml view.¿ referring to further details provided no pre-operative function check was performed, which is required per ifu.In case of any guidance inaccuracy, it would have been noticed at this time.Further, it was stated that a final position check was performed during surgery ¿yes, but the mistarget was missed.¿ what is not matching given event detail under how was issue noticed ¿after surgery¿.However, no discrepancy in guidance accuracy was reported for the required surgical step of check with the image intensifier.A physical device inspection of the item(s) in question was not possible since nothing was made available for evaluation and also a simulation of pre-functional check in combination with used counterpart was impossible.Thus, a further technical statement could not be given.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.Although an exact root cause could not be determined it could not be excluded that the event is rather related to a suboptimal intra-operative handling by the user.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.
Event or Problem Description
As reported: "the surgery was performed on (b)(6), but the two proximal lag screws were inserted off the nail.The proximal bone fragment slid 7-8 cm distally, and the femur has shortened.Revision surgery was performed on (b)(6).".

• Brand Name: LAG SCREW, RECON T2 Ø6.5X90 MM
• 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: 19055059
• Report Number: 0009610622-2024-00142
• Device Sequence Number: 20874852
• Product Code: HSB
• UDI-Device Identifier: 04546540384782
• UDI-Public: 04546540384782
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: 18976090S
• Device Lot Number: K1652D6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 75 KG