MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2353-3103

Device Problem Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Date 12/30/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "when setting nail depth version with drill tip icon wires we backed the wires of femoral neck all need, moved nail/ targeter more anterior on patient to aim more posterior for optimal version.The wire then missed the nail anterior to the nail.Caused a delay in the case to execute correct rotation of nail." length of the delay was not provided.

Manufacturer Narrative

The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Reasons for misalignment between the k-wire and the nails' drill holes are various, e.G.[but not limited to] insufficient tightening of the nail holding screw, applying too much [axial] force on the construct during drilling or unsuitable bone geometry.Functional check prior to use is required in the labelling ¿ such as ifu, op-tech and re-processing brochure.Simulation of a pre-operative functional check of returned parts with sample items revealed no deficiency in targeting accuracy.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.With available information a real definitive root cause could not be determined but it could not be excluded that it¿s rather related to a sub-optimal intraoperative procedure, which is supported by the event description ¿¿the surgeon lifted up on the targeter while nail was still in patient to attempt in sending the wires more posterior).The wire then missed the nail anterior to the nail¿¿ in case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

Event Description

As reported: "when setting nail depth version with drill tip icon wires we backed the wires.Of femoral neck all need, moved nail/targeter more anterior on patient to aim more posterior for optimal version.The wire then missed the nail anterior to the nail.Caused a delay in the case to execute correct rotation of nail." length of the delay was not provided.

• Brand Name: TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13361304
• MDR Text Key: 284896838
• Report Number: 0009610622-2022-00032
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327338652
• UDI-Public: 07613327338652
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2353-3103
• Device Catalogue Number: 23533103
• Device Lot Number: KP423047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 19 YR