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

Catalog Number 19102000

Device Problem Use of Device Problem (1670)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : not returned.

Event Description

As reported: "surgeon states that both 26mm sonic pins did not fully liquify when the ultrasonic energy was applied.Surgeon stated the pins liquefied distally and proximally but not at the center aspect.Surgeon stated this happened twice in a row with the 26mm pins.Surgeon removed the first 26mm pin but allowed the 2nd 26mm pin to remain in the patient after she removed some of the head.The surgeon used a 22mm pin right after and stated she had no issue with the 22mm pin fully liquefying.".

Event Description

As reported: "surgeon states that both 26mm sonic pins did not fully liquify when the ultrasonic energy was applied.Surgeon stated the pins liquefied distally and proximally but not at the center aspect.Surgeon stated this happened twice in a row with the 26mm pins.Surgeon removed the first 26mm pin but allowed the 2nd 26mm pin to remain in the patient after she removed some of the head.The surgeon used a 22mm pin right after and stated she had no issue with the 22mm pin fully liquefying.".

Manufacturer Narrative

Please note the correction to d4 - lot code was added.This device is concomitant and there has not been an allegation against the sonic fusion generator.The surgeon stated the generator worked fine with the 22 mm pin.It could not be excluded that it is rather related to a sub-optimal intraoperative procedure [utmost likely surgeon not using the generator correctly led to the first sonic anchor not being fully liquified].Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: SONICFUSION ULTRASONIC GENERATOR SONICPIN®
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 17676613
• MDR Text Key: 322649600
• Report Number: 0009610622-2023-00301
• 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: 11/09/2023

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: 19102000
• Device Lot Number: 19B559504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 09/04/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 49 YR
• Patient Sex: Female