MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 PROXIMAL HUMERAL NAIL - LONG NAIL- 220 MM; IMPLANT

Catalog Number UNK_KIE

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Necrosis (1971)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

The reported event that product as reported: t2 proximal humeral nail - short nail - 220 mm was alleged of issue bone fracture could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible and no additional information will be requested to the customer as this serves for trending purpose.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.Device disposition unknown.

Event Description

The manufacturer became aware of a 'retrospective data collection report' from (b)(6).The title of this study is ¿a retrospective data collection of the treatment of humeral fractures with the t2 proximal humeral nailing system (phn)¿ and is associated with the t2 proximal humeral nailing system (phn).Within that publication, post-operative complications/ adverse events were reported, which occurred between 2012 to 2017.It was not possible to ascertain specific device catalogs from the report; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication.Therefore, 30 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses lag screw protrusion (cut out).13 out of 13 cases.The report states, "a (b)(6) caucasian female (#67) suffered three adverse events.She showed necrosis of the head with cut out of a proximal screw.271 days after surgery the screw was removed.The necrosis proceeded and cut out of the remaining screws was found.711 days after surgery the implant was removed and implantation of endoprosthesis was performed.The fracture was reported as consolidated at the time of implant removal." this is pi is for cut out of the remaining screws and subsequent implant removal after 711 days.

• Brand Name: T2 PROXIMAL HUMERAL NAIL - LONG NAIL- 220 MM
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8244300
• MDR Text Key: 132948784
• Report Number: 0009610622-2019-00038
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/17/2018
• 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
• Patient Age: 67 YR
• Patient Weight: 80