MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SONICFUSION¿ ULTRASONIC GENERATOR SONICPIN®; PIN, FIXATION, SMOOTH

Model Number 1910-2000

Device Problem Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Date 11/05/2021

Event Type  malfunction  

Event Description

The customer reported the following: "on (b)(6) 2021, the sonic anchor implant was not 'melting' correctly and was pulled out of the patient's foot.Through trial and error, several more implants also failed to 'melt' correctly.Drilled and then try to implant bioabsorbable piece.Sonic anchor is only melting top portion of implant.Troubleshooted the machine today and it did not work.Surgery was completed with a sonic anchor from another company.Reporter will provide the product catalog information for the machine later.".

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Manufacturer Narrative

The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Results: visual inspection: the console was received with the warranty seal intact.Also labels were noticed on the cover.Functional inspection: the console was power cycled and able to complete the boot process.Software version: 2.10 qip10174 inspection was performed and passed.In addition the console was inspected internally for abnormalities.None were observed.The probable root could be the handpiece.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

Event Description

The customer reported the following: "on (b)(6), 2021, the sonic anchor implant was not 'melting' correctly and was pulled out of the patient's foot.Through trial and error, several more implants also failed to 'melt' correctly.Drilled and then try to implant bioabsorbable piece.Sonic anchor is only melting top portion of implant.Troubleshooted the machine today and it did not work.Surgery was completed with a sonic anchor from another company.Reporter will provide the product catalog information for the machine later.".

• Brand Name: SONICFUSION¿ ULTRASONIC GENERATOR SONICPIN®
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12928514
• MDR Text Key: 283243503
• Report Number: 0008031020-2021-00488
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613252495079
• UDI-Public: 07613252495079
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

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 Model Number: 1910-2000
• Device Catalogue Number: 19102000
• Device Lot Number: 17J585754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1