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

Model Number 1910-1271S

Device Problem Activation Failure (3270)

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

Correction: please refer to d4 lot number.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 was not possible because the correct lot number was not communicated.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: SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #2-0 / 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12925482
• MDR Text Key: 284718446
• Report Number: 0008031020-2021-00486
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613327096170
• UDI-Public: 07613327096170
• 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: 03/30/2022

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: 1910-1271S
• Device Catalogue Number: 1910-1271S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• 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: 03/03/2022
• Supplement Dates FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: No
• 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