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

Catalog Number	18220936S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0009610622-2019-00258
• Device Sequence Number: 16711413
• Product Code: HSB
• UDI-Device Identifier: 04546540197795
• UDI-Public: 04546540197795
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: 11/30/2023
• Device Catalogue Number: 18220936S
• Device Lot Number: K05D40D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 63