MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE T2 RECON; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1806-3100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the t2 recon target device 1806-3100 was used to insert a recon nail.The target device did not line up with the hole in the nail, which was discovered after the nail was inserted inside the patient.The nail was extracted and the target arm assessed on the back table.Multiple nails were then attached to the device in order to troubleshoot.The left antegrade hole in the target arm is off aim by 1cm distal to the hole in the nail.The right antegrade hole in the target arm is off by less than 1mm, which allows passage of the drill through the nail but only with resistance and difficulty.Recon mode was then selected with success, as these holes are unaffected.Additional info: "the antegrade nailing was not able to be completed successfully due to the failure of the targeting guide.However, a recon nailing of the femur was able to be performed successfully.This alternative surgery was not plan a, and did compromise the integrity of the patients femoral head when not initially required to be compromised.But the result is that the patient will not need to be re-scheduled for surgery.In summary, the initial surgery was not successful, but the alternative surgery was successful." a 25 minute intraoperative delay was reported.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the t2 recon target device 1806-3100 was used to insert a recon nail.The target device did not line up with the hole in the nail, which was discovered after the nail was inserted inside the patient.The nail was extracted and the target arm assessed on the back table.Multiple nails were then attached to the device in order to troubleshoot.The left antegrade hole in the target arm is off aim by 1cm distal to the hole in the nail.The right antegrade hole in the target arm is off by less than 1mm, which allows passage of the drill through the nail but only with resistance and difficulty.Recon mode was then selected with success, as these holes are unaffected.Additional info: "the antegrade nailing was not able to be completed successfully due to the failure of the targeting guide.However, a recon nailing of the femur was able to be performed successfully.This alternative surgery was not plan a, and did compromise the integrity of the patients femoral head when not initially required to be compromised.But the result is that the patient will not need to be re-scheduled for surgery.In summary, the initial surgery was not successful, but the alternative surgery was successful.".A 25 minute intraoperative delay was reported.
Additional Manufacturer Narrative
Please note the correction to h6 component code.The reported event could be confirmed, since the device was returned for evaluation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.In the case presented a customer experienced a delay in surgery time of appox.25 minutes.Investigation revealed that a 10-year-old target device had become impaired due to a forcefully twisted targeting component.The wrong position was detected after surgery which means that the functional check, repeatedly required in the labelling, had not been carried out.Initial de-adjusting of the affected targeting wing was caused by rough handling.As per the additional information received, no pre-surgical functional test was performed.A functional test prior to the surgery, which is required as per ifu, could have prevented the event from occurring.The event was regarded as not device related but rather caused by the user.

• Brand Name: TARGET DEVICE T2 RECON
• 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15562521
• Report Number: 0009610622-2022-00457
• Device Sequence Number: 12160863
• Product Code: HSB
• UDI-Device Identifier: 04546540654939
• UDI-Public: 04546540654939
• Combination Product (Y/N): N
• PMA/510(K) Number: K102992
• 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): 01/23/2023

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: 1806-3100
• Device Catalogue Number: 18063100
• Device Lot Number: KME903918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Male