MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SONICFUSION HANDPIECE SONICPIN; PIN, FIXATION, SMOOTH

Catalog Number	19101001
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Primary procedure, left ankle arthroscopy and lateral stabilization repair.It was reported that the wand was not functioning properly.The wand was tested on two sonic generators with the same result.Surgery was completed using competitor anchors with no delay as discovery was made while a different part of the procedure was being completed.
Additional Manufacturer Narrative
The reported event was confirmed.The device was tested using an ultrasonic generator release and revealed the hand piece being out of function.Deep cuts in the plastic material were obvious.The labelling points out that the item needs to be handled carefully.The general appearance revealed a careless handling.Such handling is regarded as user related.Review of complaint history, capa database and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated potential non-function was addressed adequately.There were no actions in place related to the reported event for the subject product.
Event or Problem Description
Primary procedure, left ankle arthroscopy and lateral stabilization repair.It was reported that the wand was not functioning properly.The wand was tested on two sonic generators with the same result.Surgery was completed using competitor anchors with no delay as discovery was made while a different part of the procedure was being completed.

• Brand Name: SONICFUSION HANDPIECE SONICPIN
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8405182
• Report Number: 0009610622-2019-00100
• Device Sequence Number: 1796097
• Product Code: HTY
• UDI-Device Identifier: 07613327096019
• UDI-Public: 07613327096019
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 19101001
• Device Lot Number: K0366B8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other