MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, PARTIALLY THREADED T2 TIBIA Ø5X35 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1891-5035S

Device Problem Positioning Failure (1158)

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

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during surgery to place a retrograde femur t2 nail, when one of the 5mm locking screws passes, it cannot be easily inserted, it becomes locked and remains blocked, without advancing.When trying to remove it with the normal screwdriver, it does not work, it rolls and decides to use the set of instruments for broken screws from the institution, and when trying to remove this piece, it remains fused with the screw.Finally, another screw is passed in the same hole, and it passes without problem.

Manufacturer Narrative

Correction: please refer to d9/h3 - device not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no additional information was provided for evaluation.A device inspection was not possible since the affected device was not returned and no other evidence was provided 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 information as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition is unknown.

Event Description

It was reported that during surgery to place a retrograde femur t2 nail, when one of the 5mm locking screws passes, it cannot be easily inserted, it becomes locked and remains blocked, without advancing.When trying to remove it with the normal screwdriver, it does not work, it rolls and decides to use the set of instruments for broken screws from the institution, and when trying to remove this piece, it remains fused with the screw.Finally, another screw is passed in the same hole, and it passes without problem.

• Brand Name: LOCKING SCREW, PARTIALLY THREADED T2 TIBIA Ø5X35 MM
• 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: 12828981
• MDR Text Key: 280887475
• Report Number: 0009610622-2021-00793
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540201928
• UDI-Public: 04546540201928
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1891-5035S
• Device Catalogue Number: 18915035S
• Device Lot Number: K0B529C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male