FDA Adverse Event Injury Summary report: N

T2 PROXIMAL HUMERAL NAIL - SHORT NAIL- 150 MM

MDR report key: 8225445 · Received January 8, 2019

Report

Report Number: 0009610622-2019-00006
Event Type: Injury
Date Received: January 8, 2019
Date of Event: January 1, 2012
Report Date: January 8, 2019
Manufacturer: STRYKER TRAUMA KIEL
Product Code: HSB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE DISPOSITION UNKNOWN.

Description of Event or Problem · 1

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 PERI-IMPLANT FRACTURE. THE REPORT STATES, "A (B)(6) CAUCASIAN FEMALE WITH A PROXIMAL HUMERAL FRACTURE TREATED WITH T2 PHN SHOWED A PERIIMPLANT FRACTURE AFTER A FALL, 116 DAYS AFTER SURGERY. THE NAIL WAS REMOVED, T2 HUMERUS NAIL WAS INSERTED AND THE PATIENT RECOVERED. (#6)"

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
21293	T2 PROXIMAL HUMERAL NAIL - SHORT NAIL- 150 MM	IMPLANT	HSB	STRYKER TRAUMA KIEL		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Required Intervention