MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECON KNOB T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2353-3301

Device Problems Failure to Align (2522); Device Damaged by Another Device (2915)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

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.

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

Correction: please refer to h6 device code, h6 clinical & health code.This device is concomitant and did not contribute to the reported failure.Since function had been confirmed for all returned product[s] the knob was classified as concomitant product ¿ it had not contributed to alleged mis guiding.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: RECON KNOB 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13361348
• MDR Text Key: 284633972
• Report Number: 0009610622-2022-00033
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327338638
• UDI-Public: 07613327338638
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2353-3301
• Device Catalogue Number: 23533301
• Device Lot Number: KP423291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: No
• 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