MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM TIBIA T2 ALPHA? TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23534107
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event that targeting arm tibia t2 alpha tibia was alleged of issue (proximal misdrilling / problems during drilling) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.The batch 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.Additional information received for the reported event indicated that ¿the surgeon did not verify alignment with the drill prior to nail insertion.When inserting the screw, the sleeve alignment was off and the screw was hitting the nail during insertion.The surgeon was able to insert the screw.The device was inspected after the surgery, and they think that the nail wasn't properly attached to the jig which made the sleeve alignment off.¿ thus, the root cause for the alleged failure can be attributed to a user related issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Surgeon reported the feedback on his 2nd and 3rd case already, in which he implanted t2 alpha tibial nails of different dimensions in the static locking mode via the suprapatellar approach.The ratings given by the surgeon are all positive; however, as part of the additional comments made, a complication was also reported in the feedback on case #040.Nail cross threaded onto the jig and missed one of the proximal lockers.Indicated as an observed deficiency / complication.

• Brand Name: TARGETING ARM 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
• MDR Report Key: 8409351
• Report Number: 0009610622-2019-00104
• Device Sequence Number: 13965769
• Product Code: HSB
• UDI-Device Identifier: 07613327357080
• UDI-Public: 07613327357080
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K180436
• 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): 03/11/2019

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 Catalogue Number: 23534107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other