MAUDE Adverse Event Report: STRYKER GMBH UNK SONICANCHOR; IMPLANT

Catalog Number UNK_SEL

Device Problem Insufficient Information (3190)

Patient Problem Impaired Healing (2378)

Event Date 05/26/2018

Event Type  Injury  

Manufacturer Narrative

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

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 published in november 2018 and is associated with the stryker sonicanchor.Within that publication, post-operative complications/ adverse events were reported, which occurred between 26-may-2016 to 1-aug-2018.It was not possible to ascertain specific device and/or patient information from the report; a review of the complaint handling database, however, revealed that the events have not been reported previously by the hospital or by the author of the publication.Therefore, 13 complaints were initiated retrospectively for the different adverse events mentioned in the report.This product inquiry addresses aseptic wound healing problems.3 out of 4 cases.

• Brand Name: UNK SONICANCHOR
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8095606
• MDR Text Key: 128099682
• Report Number: 0008031020-2018-00998
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• 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
• Date Manufacturer Received: 11/15/2018
• 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