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

Catalog Number 23533103

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2023

Event Type  malfunction  

Event Description

As reported: during placement of a recon lag screw in recon mode, an attempt to insert a k-wire interfered with the nail, making it difficult to insert the k-wire.The proximal side also interfered with the drill and nail and the surgeon managed to insert the lag screw, but it was confirmed that the proximal lag screw was inserted forward of the nail.After removing the lag screw, the surgeon reinserted the k-wire and managed to fix the two lag screws.Even after screw insertion, the sleeve did not come off the targeting arm smoothly.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "during placement of a recon lag screw in recon mode, an attempt to insert a k-wire interfered with the nail, making it difficult to insert the k-wire.The proximal side also interfered with the drill and nail and the surgeon managed to insert the lag screw, but it was confirmed that the proximal lag screw was inserted forward of the nail.After removing the lag screw, the surgeon reinserted the k-wire and managed to fix the two lag screws.Even after screw insertion, the sleeve did not come off the targeting arm smoothly.".

Manufacturer Narrative

The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.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 device inspection revealed the following: using sample sleeves and sample knob, a sample k-wire could be placed as intended.The k-wire did not deflect causing a misplacement of the lags screws nor did the k-wire contact the nail in any way.Placing the ¿thumb¿-handles in opposite position ¿ 1 unit up, 1 unit down ¿ ensures easy insertion resp.Easy removal of the sleeves.The knob has to be locked firmly.The alleged event could not be re-produced.A deflection of the k-wire was not observed.The sleeves could easily be removed as intended.Based on investigation, the failure was caused by making a mistake.The root cause was attributed to a user related issue.

• Brand Name: TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE
• Type of Device: 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: 16610697
• MDR Text Key: 312353207
• Report Number: 0009610622-2023-00086
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K203819
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 23533103
• Device Lot Number: KP472985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2022
• 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