MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 FE RETRO NAIL LNG D11XL360; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2339-1136S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 02/06/2023

Event Type  Injury  

Event Description

It was reported that the patient was brought back to revise an interlocking screw that was backing out and take out antibiotic spacer.Minifrag and small frag plating, along with bone grafting were used during the revision.

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 patient was brought back to revise an interlocking screw that was backing out and take out antibiotic spacer.Minifrag and small frag plating, along with bone grafting were used during the revision.

Manufacturer Narrative

Please note the correction to d9/h3 as the device was not returned for evaluation.The received x-rays were reviewed and it can be confirmed that a the third locking screw on the distal end of the nail is dislocated.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.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.No indications of material, manufacturing or design related problems were found during the investigation.The complaint was forwarded to medical affairs for review with following feedback: "the x-ray shows a devastating supracondylar fracture with involvement of the articular surface and the patella.There is a very large metaphyseal defect that has been laterally supported with bone cement.While there is the retrograde nail introduced intracondylar, small fragment osteosynthesis has been performed in the medial and lateral condyle and medially at the transition of the diaphysis to the upper metaphysis.In the ap-view we can also see, that the joint line is far from being horizontal with the medial condyle being further distal then the lateral, a finding which suggests a lack of stability laterally, here.The overall bone quality appears alarmingly poor.With the given combination of osteosynthesis (nail, plate, free screws, bone cement) all defects have been addressed from a surgical perspective, the postoperative mobilization with touch down weight bearing seems adequate.In conclusion, it can be said that there are strong patient related factors: poor bone quality and the disastrous fracture pattern.Both have contributed to the instability of the whole-more or less loose-articular fragment which is almost without any bony connection to the shaft portion of the bone.This instability led to a minimal tilting movement that was transmitted to the screw and ended in the migration of the screw." based on investigation, the root cause was attributed to a patient related issue.The dislocation of the locking screw in the nail hole was caused by the above described patient related factors.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

• Brand Name: T2 FE RETRO NAIL LNG D11XL360
• 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: 16466515
• MDR Text Key: 310496524
• Report Number: 0009610622-2023-00071
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327293593
• UDI-Public: 07613327293593
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2339-1136S
• Device Catalogue Number: 23391136S
• Device Lot Number: K04FA1F
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 86 KG