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

Model Number 1806-3100

Device Problem Failure to Align (2522)

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

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that "the recon targeting arm caused the drill to miss both antegrade and recon mode screws." surgeon had to use recon screws instead of antegrade on a young patient.Surgeon had to freehand lock the recon screws.There was a surgical delay of 60 minutes.

Event Description

It was reported that "the recon targeting arm caused the drill to miss both antegrade and recon mode screws." surgeon had to use recon screws instead of antegrade on a young patient.Surgeon had to freehand lock the recon screws.There was a surgical delay of 60 minutes.

Manufacturer Narrative

Please note the correction to h6 component code.The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.Although a real root cause could not be determined the alleged event is most likely caused due to a sub-optimal intraoperative procedure and has to be classified as user-customer-user error.Pre-supposing that positioning accuracy for drilling was confirmed by pre-operative check performed, which is required per ifu, it was concluded that the event was mainly based in the medical procedure.Finally, each device suffers from a long and intensive use and since the device has been in use for a longer time [manufactured 2012] it has reached the end of its useful service-life.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 case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: TARGET DEVICE T2 RECON
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15034003
• MDR Text Key: 304555292
• Report Number: 0009610622-2022-00330
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540654939
• UDI-Public: 04546540654939
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

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
• Device Operator: Health Professional
• Device Model Number: 1806-3100
• Device Catalogue Number: 18063100
• Device Lot Number: KME904465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 11/04/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1