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

Catalog Number UNK_KIE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided in a supplemental.Device is not available to stryker.

Event Description

Stryker became aware of an article published in the ¿journal of the chinese medical association¿, ¿risk factors for cutout failure of gamma3 nails in treating unstable intertrochanteric fractures¿ published in september 29, 2016 and is associated with gamma3 trochanteric nails.An analysis of 176 patients, which was within that publication, 24 postoperative complications/ adverse events were reported, which occurred between 2010 and 2014.It was not possible to ascertain specific device or patient information from the article.A review of the complaint handling databases however revealed that the events had not been reported by the hospital or by the author of the publication, therefore 24 events were initiated retrospectively.This product inquiry addresses a cutout failure for an unknown gamma3 trochanteric nail.

• Brand Name: UNKNOWN GAMMA3 TROCHANTERIC NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: melissa guattery ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7389949
• MDR Text Key: 104136049
• Report Number: 0009610622-2018-00104
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• 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