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

Model Number 2353-4105

Device Problems Component Missing (2306); Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2020

Event Type  malfunction  

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 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
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10701923
• MDR Text Key: 219335355
• Report Number: 0009610622-2020-00567
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 2353-4105
• Device Catalogue Number: 23534105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse