MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN EXTERNAL FIXATORS - HOFFMANN II; IMPLANT

Catalog Number UNK_SEL

Device Problem Insufficient Information (3190)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/01/2009

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer became aware of a study from kobe university graduate school of medicine, kobe, japan.The title of this report is ¿ankle arthrodesis using antegrade intramedullary nail for salvage of nonreconstructable tibial pilon fractures¿, which was published on 1-august-2009 and is associated with external fixators - hoffmann ii.Within that publication, post-operative complications/ adverse events were reported.It was not possible to ascertain specific device or patient information from the report; a review of the complaint handling database, however, revealed that the events have not been reported previously.Therefore, 2 complaints were initiated retrospectively for the adverse events mentioned in the report.This product inquiry addresses unacceptable reduction.1 out of 2 cases.

• Brand Name: UNKNOWN EXTERNAL FIXATORS - HOFFMANN II
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8084323
• MDR Text Key: 127562154
• Report Number: 0008031020-2018-00995
• Device Sequence Number: 1
• Product Code: KTT
• 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: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/19/2018
• 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): Other