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

Model Number	1910-2000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem 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.".
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Additional 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 or Problem 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®
• Common Device Name: 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
• Report Number: 0008031020-2021-00488
• Device Sequence Number: 19863012
• Product Code: HTY
• UDI-Device Identifier: 07613252495079
• UDI-Public: 07613252495079
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091955
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown