MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL T2 ALPHA? TIBIA Ø12X285MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2341-1228S
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Insufficient Information (4580)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device remains implanted in patient.
Event or Problem Description
It was reported that an als backed out from the t2 alpha tibial nail.The patient has a history of stroke and is on dialysis due to diabetes.The subject advanced locking screw was inserted in the fourth hole from the proximal, but there was almost no engagement between the screw and cortical bone due to overlap with the screw hole position at the primary surgery.The primary surgery was performed with another companies' nail and the revision surgery was performed with t2 alpha on (b)(6) 2022, because of pseudarthrosis.In addition, the patient did not listen to the surgeon's instructions on movement restrictions, etc.Only the screw that backed out was removed on (b)(6) 2022.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The patient has a history of stroke and is on dialysis due to diabetes.The subject advanced locking screw was inserted in the fourth hole from the proximal, but there was almost no engagement between the screw and cortical bone due to overlap with the screw hole position at the primary surgery.The primary surgery was performed with other companies' nail and the revision surgery was performed with t2 alpha on (b)(6) 2022 because of pseudarthrosis.In addition, the patient did not listen to the surgeon's instructions on movement restrictions, etc.Manufacturing documents revealed no deficiency.The item had left the premises in intended condition.No further complaints including this lot have been reported.According to received information the patient had not been compliant.The root cause was classified as not product related but rather as patient related.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that an als backed out from the t2 alpha tibial nail.The patient has a history of stroke and is on dialysis due to diabetes.The subject advanced locking screw was inserted in the fourth hole from the proximal, but there was almost no engagement between the screw and cortical bone due to overlap with the screw hole position at the primary surgery.The primary surgery was performed with another companies' nail and the revision surgery was performed with t2 alpha on (b)(6) 2022, because of pseudarthrosis.In addition, the patient did not listen to the surgeon's instructions on movement restrictions, etc.Only the screw that backed out was removed on (b)(6) 2022.

• Brand Name: TIBIAL NAIL T2 ALPHA? TIBIA Ø12X285MM
• 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: 16019528
• Report Number: 0009610622-2022-00599
• Device Sequence Number: 5883514
• Product Code: HSB
• UDI-Device Identifier: 07613327291254
• UDI-Public: 07613327291254
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2341-1228S
• Device Catalogue Number: 23411228S
• Device Lot Number: K0437D9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 74 KG