MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ONE SHOT TARGET DEVICE GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	13203010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that when the one shot device was used it was noticed that the lines one x-ray indicating lag screw position did not align with the hole in the nail.Looking along the length of the one shot device it was noted that there was a twist along its length.Procedure was completed successfully with no surgical delay or adverse consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed that the returned one shot target device (osd) shows traces of usage.The original white printing had turned to light beige over time.The shaft is slightly twisted.Placed on a plain surface a deformation of the shaft is visible [gap visible between shaft and plain surface.Functional inspection: the function of the osd could not be tested as this will require an x-ray image intensifier which is not available.However, with regard to evident damage it is obvious that function is not given any more on the instrument.Dimensional inspection: a dimensional examination was not applicable, refer to functional inspection.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.No corrective actions are required at this time.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by insufficient handling during sterilization.The deformations are a result of bending forces during reprocessing, most likely caused by loaded instruments on the osd.
Event or Problem Description
It was reported that when the one shot device was used it was noticed that the lines one x-ray indicating lag screw position did not align with the hole in the nail.Looking along the length of the one shot device it was noted that there was a twist along its length.Procedure was completed successfully with no surgical delay or adverse consequences reported.

• Brand Name: ONE SHOT TARGET DEVICE GAMMA3®
• 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: 8922764
• Report Number: 0009610622-2019-00623
• Device Sequence Number: 1978507
• Product Code: HSB
• UDI-Device Identifier: 04546540396860
• UDI-Public: 04546540396860
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 11/22/2019

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: 13203010
• Device Lot Number: KME906237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1