MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18220936S

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The following event was reported to ansm by the doctor: " (b)(6)-year-old patient, managed for osteosynthesis by centromedullary nailing of the right tibia.Drilling of the tibia and insertion of the guide rod centered in the front and profile pin, then impossibility to bring out the guide rod of the nail." remove the nail with the guide rod and install a new nail.Unknown amount of extension of the surgical procedure was reported.

Manufacturer Narrative

Correction: sections d10 (concomitant medical products), h3 (device evaluated by mfr).The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided for investigation.A device inspection was not possible since the affected device was not returned for evaluation and no other evidence was provided for investigation.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.However, based on complaint history and risk management file some of the possible causes of this failure are: strong bent in wire tip, cannulation clogged etc.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 manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device not available.

Event Description

The following event was reported to ansm by the doctor: " 17-year-old patient, managed for osteosynthesis by centromedullary nailing of the right tibia.Drilling of the tibia and insertion of the guide rod centered in the front and profile pin, then impossibility to bring out the guide rod of the nail." remove the nail with the guide rod and install a new nail.Unknown amount of extension of the surgical procedure was reported.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 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
• MDR Report Key: 8625601
• MDR Text Key: 145941597
• Report Number: 0009610622-2019-00258
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540197795
• UDI-Public: 04546540197795
• Combination Product (y/n): N
• PMA/PMN Number: K003018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 18220936S
• Device Lot Number: K05D40D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 63