MAUDE Adverse Event Report: STRYKER GMBH SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #0 / C-2; PIN, FIXATION, SMOOTH

Model Number 1910-1272S

Device Problems Positioning Failure (1158); Activation Failure (3270)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2023

Event Type  malfunction  

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

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

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.H3 other text: device disposition is unknown.

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: SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #0 / C-2
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16254618
• MDR Text Key: 308489187
• Report Number: 0008031020-2023-00033
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613327096163
• UDI-Public: 07613327096163
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143063
• 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: 05/16/2023

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 Expiration Date: 03/14/2023
• Device Model Number: 1910-1272S
• Device Catalogue Number: 1910-1272S
• Device Lot Number: 1000484878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/27/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male