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

Model Number	1806-0050S
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem 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.".
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0009610622-2021-00563
• Device Sequence Number: 3426242
• Product Code: LXH
• UDI-Device Identifier: 04546540195852
• UDI-Public: 04546540195852
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 87