MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DISTAL TARGETING DEVICE GAMMA3® DISTAL TARGETING R2.0; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	13205320
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Visual inspection: revealed no physical damage to both devices.Functional inspection: gamma 3 targeting arm and the fixation bolt were used to perform functional test of reported gamma 3 targeting devices.The devices functioned perfectly as expected.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by not adhering to the instructions of the optech during device assembly.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Our agent, during a workshop, found that one device: after having mounted the dts arm on the carbon handle of the gamma cod.1320-0111 on which a right gamma 3 long nail was mounted, it was absolutely not possible to insert the pin cod.1320-5330 which remained completely out of the hole.Simulating instead the use of a left nail, the pin cod.1320-5330 entered in part, resulting however decentralized with respect to the exit hole.The other device (same lot): mounting the arm on the gamma3 carbon device and inserting the locking pin, the pin itself did not engage, being off-center with respect to the exit hole.The problem occurs only on the long dx nail, not on the left.He tried with another device (different lot) whit no issue.No patient involvement, no associated procedure.

• Brand Name: DISTAL TARGETING DEVICE GAMMA3® DISTAL TARGETING R2.0
• 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: 9555453
• Report Number: 0009610622-2020-00001
• Device Sequence Number: 13973612
• Product Code: HSB
• UDI-Device Identifier: 07613154985760
• UDI-Public: 07613154985760
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K123401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2020

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: Other
• Device Catalogue Number: 13205320
• Device Lot Number: KP432136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1