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

Catalog Number UNK_KIE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Date 07/14/2022

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of delayed union, which required revision, could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The post market clinical team has conducted a follow-up report on ¿a retrospective data collection of the treatment of tibia fractures with the t2 alpha tibia nailing system¿.The study was conducted at ¿bg unfallklinik murnau, germany'.The report is associated with the stryker ¿t2 alpha tibia nailing system¿ and includes an analysis of the clinical data that was collected on 22 patients.The cases in the study range from may 2019 and june 2021.The report indicates that one (1) patient experienced delayed union; therefore, the proximal screw was removed for dynamization.

Manufacturer Narrative

Please note correction to h6 (clinical code).

Event Description

The post market clinical team has conducted a follow-up report on ¿a retrospective data collection of the treatment of tibia fractures with the t2 alpha tibia nailing system¿.The study was conducted at ¿bg unfallklinik murnau, germany'.The report is associated with the stryker ¿t2 alpha tibia nailing system¿ and includes an analysis of the clinical data that was collected on 22 patients.The cases in the study range from may 2019 and june 2021.The report indicates that one (1) patient experienced delayed union; therefore, the proximal screw was removed for dynamization.

• Brand Name: UNKNOWN T2 ALPHA TIBIA NAIL
• 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: 15194153
• MDR Text Key: 297570692
• Report Number: 0009610622-2022-00360
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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