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

Catalog Number UNK_KIE

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

Patient Problems Failure of Implant (1924); Perforation (2001)

Event Date 07/28/2014

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of cut out and fracture fixation failure, requiring 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.Device disposition unknown.

Event Description

The manufacturer became aware of a literature published by the ¿(b)(6) hospital, department of orthopaedics, united states.¿ the title of this report is, ¿is distal locking of long nails for intertrochanteric fractures necessary? a clinical study,' published on (b)(6) 2014, which is associated with the stryker ¿gamma-3 nailing system.¿ the article can be found at http://dx.Doi.Org/10.1016/j.Jcot.2014.06.001.This report includes an analysis of the clinical data that was collected on 107 patients, and the cases in this study range from 2006 to 2012.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 cut out and fracture fixation failure, requiring revision.The report states that, ¿fracture fixation failed secondary to cutout of the lag screw 4 months after initial fixation.Revision to calcar replacing hemiarthroplasty was required.¿.

Event Description

The manufacturer became aware of a literature published by the ¿rhode island hospital, department of orthopaedics, united states¿.The title of this report is, ¿is distal locking of long nails for intertrochanteric fractures necessary? a clinical study¿, published on july 28, 2014, which is associated with the stryker ¿gamma-3 nailing system¿.The article can be found at http://dx.Doi.Org/10.1016/j.Jcot.2014.06.001.This report includes an analysis of the clinical data that was collected on 107 patients, and the cases in this study range from 2006 to 2012.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 cut out and fracture fixation failure, requiring revision.The report states that, ¿fracture fixation failed secondary to cutout of the lag screw 4 months after initial fixation.Revision to calcar replacing hemiarthroplasty was required ¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of cut out and fracture fixation failure, requiring revision could be confirmed, from the available radiographs in the literature.Based on the available information and the x-ray a formal medical opinion was sought that the initial x-ray reveals reasonable fracture repositioning.It also shows a good lag screw position.The treatment looks fine.The reason behind the alleged failure is most likely patient related osteopenic bone structure, as there is no clear sign of a significant reduction of the tad and thus a technical/operative underlying cause.Based on the above investigation root cause primarily can be attributed to be patient related factors.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

• 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: 14755304
• MDR Text Key: 294407861
• Report Number: 0009610622-2022-00266
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: 07/12/2022
• 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