MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE, STERILE T2 FEMUR 3X285 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 1806-0050S

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported: "in the procedure of the t2 femur nail, due to the complexity of the fracture, guide pins are passed, and the guide needle is passed 18060050s for the placement of the screw, the resident cuts the pins that have been passed to reduce the fracture and between them cut the guide needle through error, so the surgeon decided to leave the guide needle to help in reducing the fracture.".

Manufacturer Narrative

D9 / h3 updated to indicate device was not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned 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.A review of the labeling did not indicate any abnormalities.The operative technique instructs user that: ¿while removing the power tool the guide wire pusher will keep the guide wire in place.Remove the guide wire prior to drilling and inserting the locking screws.¿ 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.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

As reported: "in the procedure of the t2 femur nail, due to the complexity of the fracture, guide pins are passed, and the guide needle is passed 18060050s for the placement of the screw, the resident cuts the pins that have been passed to reduce the fracture and between them cut the guide needle through error, so the surgeon decided to leave the guide needle to help in reducing the fracture.".

• Brand Name: K-WIRE, STERILE T2 FEMUR 3X285 MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 12018162
• MDR Text Key: 259589742
• Report Number: 0009610622-2021-00563
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540195852
• UDI-Public: 04546540195852
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 1806-0050S
• Device Catalogue Number: 18060050S
• Device Lot Number: K096E14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 87