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

Model Number 1910-2000

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "my team did not have a rep available to cover this case.As i was in a separate case, i stepped out for a phone call from my colleague who stated that the facility needed to troubleshoot and she wasn't aware.I gave them a call and walked them through the stryker sonic anchor trouble shooting per the technique guide.As nobody was physically there, i do not know if my troubleshoot actions were taking.The facility states that they did all of the actions (unplugging machine, taking off the tip of the handpiece and re attaching, restarting, running a test prior).They claim that they generator was faulty and it was not allowing them to run the "test run".I was then hung up on by the facility.I get a text message from the facility materials manager stating that the sonic anchor did not work, and he sent me a photo of the box.Apparently they opened and anchor and tried to use it.I do not know exactly what happened here as they should not have opened the anchor prior to doing the test run.While i was on speaker phone trying to trouble shoot, the doctor said "this patient has been under for 3 hours, this anchor doesn't work.There is nobody here" and proceeding to hang up on me.There were not any adverse consequences to the patient due to the surgical delay that i know of, they ended up using a suture to complete the repair.They used the drill hole in the bone initially for the anchor, but just sutured the tendon and pulled that through.It did power on, it would not generate the ultrasonic energy needed to complete a successful "test".I was not there but from the conversation i had on the phone, and error message appeared." the sales rep reported that they were on the phone for about 10 minutes, but they are unsure of how long the facility tried to get it to work before calling them or if they tried any longer after they hung up.

Manufacturer Narrative

Please note the corrections to d4 lot#.Pac: review of capa database and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated non-function was addressed adequately.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.Sj: the sonicfusion console was received with the warranty seal intact.Labels on the cover were noticed.Functional inspection: then the console was powered on and a l01000 lockdown error appeared on the display screen.Unable to complete the boot process.The probable root cause could be a main board non conforming component due to possible user misuse.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be a main board non conforming component due to possible user misuse.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

As reported: "my team did not have a rep available to cover this case.As i was in a separate case, i stepped out for a phone call from my colleague who stated that the facility needed to troubleshoot and she wasn't aware.I gave them a call and walked them through the stryker sonic anchor trouble shooting per the technique guide.As nobody was physically there, i do not know if my troubleshoot actions were taking.The facility states that they did all of the actions (unplugging machine, taking off the tip of the handpiece and re attaching, restarting, running a test prior).They claim that they generator was faulty and it was not allowing them to run the "test run".I was then hung up on by the facility.I get a text message from the facility materials manager stating that the sonic anchor did not work, and he sent me a photo of the box.Apparently they opened and anchor and tried to use it.I do not know exactly what happened here as they should not have opened the anchor prior to doing the test run.While i was on speaker phone trying to trouble shoot, the doctor said "this patient has been under for 3 hours, this anchor doesn't work.There is nobody here" and proceeding to hang up on me.There were not any adverse consequences to the patient due to the surgical delay that i know of, they ended up using a suture to complete the repair.They used the drill hole in the bone initially for the anchor, but just sutured the tendon and pulled that through.It did power on, it would not generate the ultrasonic energy needed to complete a successful "test".I was not there but from the conversation i had on the phone, and error message appeared." the sales rep reported that they were on the phone for about 10 minutes, but they are unsure of how long the facility tried to get it to work before calling them or if they tried any longer after they hung up.

• 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: 16254617
• MDR Text Key: 308942577
• Report Number: 0009610622-2023-00019
• 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: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• 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: 16I003094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2016
• 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 Sex: Male