MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 LAG SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Swelling/ Edema (4577)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of lag screw protrusion and effusion from the skin, 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's medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.Additionally, the device history record could not be reviewed because the affected lot number(s) was not communicated.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 ¿sasebo kyosai hospital orthopedic surgery, japan ¿.The title of this report is, ¿a case of dislocation without cause after osteosynthesis for a femoral intertrochanteric fracture ¿, published on december 14, 2017, which is associated with the stryker ¿gamma 3 nailing system¿.The article can be found at doi: https://doi.Org/10.5035/nishiseisai.66.842.This report includes an analysis of the clinical data that was collected on 1 patient.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced lag screw protrusion and effusion from the skin, which required revision.The report states, ¿although no re-dislocation was observed as of four months after the original dislocation, because there was lag screw protrusion and effusion from the skin was observed, the original lag screw was replaced with a short lag screw.¿.

• Brand Name: UNKNOWN GAMMA 3 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: 14680822
• MDR Text Key: 293936666
• Report Number: 0009610622-2022-00252
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• 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: 05/19/2022
• 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