MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 TROCHANTERIC NAIL CASE 4; IMPLANT

Catalog Number UNK_KIE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

This product inquiry addresses 2 intra-operative distal locking screw outside in conjunction to the sgn system and 4 intra-operative distal locking screw outside in conjunction to the gamma3 system.Screws were revised.It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database revealed that the events had not been reported by the hospital or by the author of the publication, therefore 11 complaints were initiated retrospectively.The manufacturer became aware by an (b)(6) publication ¿how evolution of the nailing system improves results and reduces orthopedic complications: more than 2000 cases of trochanteric fractures treated with the gamma nail system¿, published on 14th december 2015 regarding the gamma system (sgn, tgn, gamma3 ¿ all trochanteric nails) that in sum 63 patients had been observed presenting 11 adverse events in a period from january 1997 to december 2011.

Manufacturer Narrative

Corrections to describe event or problem.

Event Description

This product inquiry addresses 3 intra-operative distal locking screw outside in conjunction to the sgn system and 4 intra-operative distal locking screw outside in conjunction to the gamma3 system.This product inquiry addresses 3 intra-operative distal locking screw outside in conjunction to the sgn system and 4 intra-operative distal locking screw outside in conjunction to the gamma3 system.The manufacturer became aware by an italian publication ¿how evolution of the nailing system improves results and reduces orthopedic complications: more than 2000 cases of trochanteric fractures treated with the gamma nail system¿, published on 14th december 2015 regarding the gamma system (sgn, tgn, gamma3 ¿ all trochanteric nails) that in sum 63 patients had been observed presenting 11 adverse events in a period from january 1997 to december 2011.It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database revealed that the events had not been reported by the hospital or by the author of the publication, therefore 11 complaints were initiated retrospectively.

• Brand Name: UNKNOWN GAMMA3 TROCHANTERIC NAIL CASE 4
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6123240
• MDR Text Key: 60749031
• Report Number: 0009610622-2016-00538
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/27/2016
• 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