MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADJUSTING DEVICE TIBIA T2 ALPHA TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2353-4105
Medical Device Problem Codes	Component Missing (2306); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.¿ 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 risk management file review, possible cause of failure could be user related issue- the adjusting device pin was missing (loss during cleaning and checking set), without which adjusting device cannot be attached to target device for distal drilling.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "the distal adjusting device pin was missing.The doctor didn't notice it, and a drill was inserted in the ankle surface.Miss drilling has occurred.".

• Brand Name: ADJUSTING DEVICE TIBIA T2 ALPHA TIBIA
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10701923
• Report Number: 0009610622-2020-00567
• Device Sequence Number: 19626759
• Product Code: HSB
• UDI-Device Identifier: 07613327357073
• UDI-Public: 07613327357073
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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 Model Number: 2353-4105
• Device Catalogue Number: 23534105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50