MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #2 / C-7; PIN, FIXATION, SMOOTH

Catalog Number 1910-1273S

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

One of the four anchors implanted did not liquefy.It popped out of pilot hole when tying sutures and was still in its original cylindrical shape.

• Brand Name: SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #2 / C-7
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• 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: 5539177
• MDR Text Key: 41778000
• Report Number: 0008010177-2016-00061
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101056
• 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: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1910-1273S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 03/31/2016
• 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