MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 LAG SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿department of orthopaedic surgery and traumatology, zuyderland medical centre, sittard-geleen and heerlen, the netherlands¿.The article can be found at http://www.Actaorthopaedica.Be/archive/volume-86/issue-4/original-studies/comparable-clinical-and-radiographical-outcomes-between-second-and-third-generation-of-gamma-nails/.The reported event 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's medical history, the event details and the involved device(s) must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The manufacturer became aware of a literature published by the ¿department of orthopaedic surgery and traumatology, zuyderland medical centre, sittard-geleen and heerlen, the netherlands.¿.The title of this report is ¿comparable clinical and radiographical outcomes between second and third generation of gamma nails ¿, published on december 01, 2020, and can be found at http://www.Actaorthopaedica.Be/archive/volume-86/issue-4/original-studies/comparable-clinical-and-radiographical-outcomes-between-second-and-third-generation-of-gamma-nails/.The report is associated with the stryker ¿trochanteric gamma and gamma 3 nailing systems¿ and includes an analysis of the clinical data that was collected on 291 patients.The cases in this study range from january 2005 to july 2012.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information, however the article alleges that 1 patient experienced lag screw medialization with a gamma 3 short nail.

Manufacturer Narrative

Correction - h6: device code.

Event Description

The manufacturer became aware of a literature published by the ¿department of orthopaedic surgery and traumatology, (b)(6) medical centre, sittard-geleen and heerlen, the netherlands.¿.The title of this report is ¿comparable clinical and radiographical outcomes between second and third generation of gamma nails ¿, published on december 01, 2020, and can be found at http://www.Actaorthopaedica.Be/archive/volume-86/issue-4/original-studies/comparable-clinical-and-radiographical-outcomes-between-second-and-third-generation-of-gamma-nails/.The report is associated with the stryker ¿trochanteric gamma and gamma 3 nailing systems¿ and includes an analysis of the clinical data that was collected on 291 patients.The cases in this study range from january 2005 to july 2012.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information, however the article alleges that 1 patient experienced lag screw medialization with a gamma 3 short nail.

• Brand Name: UNKNOWN GAMMA3 LAG SCREW
• 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: 15833294
• MDR Text Key: 303996643
• Report Number: 0009610622-2022-00523
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 12/21/2022
• 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): Other