MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNK SONICANCHOR; IMPLANT

Catalog Number UNK_KIE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Embolism (1498)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6).The title of this report is ¿a post-market clinical follow-up (pmcf) of the fixation of sutures and soft tissue with the sonicanchor¿ which was released in june 2018 and is associated with the stryker sonic anchor system, within that report, postoperative complications/ adverse events were reported, which occurred between february 2016 and april 2018.It was not possible to ascertain specific device or patient information from the article, 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 report, therefore 12 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses pulmonary embolism.

• Brand Name: UNK SONICANCHOR
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: melissa guattery ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7723569
• MDR Text Key: 115189816
• Report Number: 0009610622-2018-00401
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/26/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/26/2018
• 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