MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Malposition of Device (2616)

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

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.

Event Description

The manufacturer became aware of a literature published by lincoln county hospital in united kingdom.The title of this report is ¿late medial migration of lag screw after gamma3 nailing threatening the internal iliac vessels¿ published on september 1, 2020, which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at http://dx.Doi.Org/10.2106/jbjs.Cc.19.00623.This report includes research done on 1 patient.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses lag screw medial migration into the pelvis which required revision surgery.The report states: ¿eight months later, during investigations for unrelated vascular problems in the contralateral leg, it was identified that the lag screw on the left side had migrated medially into the pelvis and was in contact with the internal iliac vessels with complete collapse at the fracture site.She was reviewed urgently.A preoperative computed tomography angiogram was performed.This revealed that the screw was adjacent to the internal iliac vessels, and hence, a vascular team involvement was sought.After a multidisciplinary team meeting, it was decided to embolize the internal iliac vessels to prevent bleeding during the removal of screw and conversion to total hip replacement.The patient underwent successful embolization 2 days before the procedure.We approached the hip through a posterior approach.The nail was removed, and the hip joint was exposed.The lag screw was identified deep in the acetabulum and removed with no obvious bleeding from the screw track.Observation up to 10 minutes subsequent to the screw removal showed no hemodynamic compromise.We proceeded to reconstruct the hip using an uncemented implant.¿.

• Brand Name: UNKNOWN GAMMA3 NAIL
• Type of Device: IMPLANT
• 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: 12166257
• MDR Text Key: 261643844
• Report Number: 0009610622-2021-00592
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• 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: 06/16/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR