MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 TIBIA NAIL

Catalog Number UNK_KIE

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problems Complaint, Ill-Defined (2331); No Information (3190); No Code Available (3191)

Event Date 10/31/2004

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Product disposition is not known.

Event Description

The manufacturer became aware of a post-market product surveillance from (b)(6).The title of this report is ¿international multicentre post-market product surveillance - t2 humeral nailing system antegrade vs.Retrograde approach¿ which was released on (b)(6) 2018 and is associated with the t2¿ humeral nailing system.Within that report, intraoperative and post-operative complications/ adverse events were reported.It was not possible to ascertain specific information or patient information from the article.A review of the complaint handling database revealed that the events have not been reported by the hospital or by the author of the publication, therefore 12 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses fracture at entry point.One out of 2 cases.The report states: ¿in two cases a fracture at the nail entry point occur (3.6%).In one of the cases it becomes necessary to revise the patient to a plate six month postoperatively (loosening of the nail).¿.

Event Description

The manufacturer became aware of a post-market product surveillance from bg unfallklinik, murnau, germany.The title of this report is ¿international multicentre post-market product surveillance - t2 humeral nailing system antegrade vs.Retrograde approach¿ which was released on 31-10-2018 and is associated with the t2¿ humeral nailing system.Within that report, intraoperative and post-operative complications/ adverse events were reported.It was not possible to ascertain specific information or patient information from the article.A review of the complaint handling database revealed that the events have not been reported by the hospital or by the author of the publication, therefore 12 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses fracture at entry point.1 out of 2 cases.The report states: ¿in two cases a fracture at the nail entry point occur (3.6%).In one of the cases it becomes necessary to revise the patient to a plate six month postoperatively (loosening of the nail).¿.

Manufacturer Narrative

Corrected from 5 day report to initial report.

• Brand Name: UNKNOWN T2 TIBIA NAIL
• Type of Device: UNK
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7899085
• MDR Text Key: 241263301
• Report Number: 0009610622-2018-01061
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

2 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention