MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL T2 ALPHA? TIBIA Ø12X315MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2341-1231S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available as the device remains implanted.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported: "a case of tibial diaphyseal fracture was operated with t2 alpha tibial nail on (b)(6) 2021.After surgery, pseudoarthrosis was confirmed, and the patient is scheduled for revision surgery on (b)(6) 2021 for curettage of the pseudoarthrosis, bone grafting, and augmentation plate placement.".
Additional Manufacturer Narrative
The alleged event ¿ non-union ¿ was not confirmed because the device is still implanted.No other evidence was provided.Review of dhr, complaint history, capa databases and risk analysis did not identify any new discrepancies.There are no open actions in place related to the reported event for the subject product.It was reported that pseudoarthrosis was confirmed.It was further confirmed that no implant was removed, because undamaged, and bone was grafted from the iliac and augmented with varix plate.The labelling points out potential effects contributing to impaired bone healing.With above information a deficiency of the device was not verified.The cause of the event was regarded as patient related.
Event or Problem Description
It was reported: "a case of tibial diaphyseal fracture was operated with t2 alpha tibial nail on (b)(6) 2021.After surgery, pseudoarthrosis was confirmed, and the patient is scheduled for revision surgery on (b)(6) 2021 for curettage of the pseudoarthrosis, bone grafting, and augmentation plate placement." update: the revision was done on (b)(6).No implant was removed and bone grafted from iliac and augmented with variax plate.

• Brand Name: TIBIAL NAIL T2 ALPHA? TIBIA Ø12X315MM
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12734110
• Report Number: 0009610622-2021-00770
• Device Sequence Number: 17373483
• Product Code: HSB
• UDI-Device Identifier: 07613327291155
• UDI-Public: 07613327291155
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 2341-1231S
• Device Catalogue Number: 23411231S
• Device Lot Number: K05C1A3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown