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

Model Number	1910-1271S
Medical Device Problem Code	Activation Failure (3270)
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
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 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: SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #2-0 / C-2
• Common Device Name: 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
• Report Number: 0008031020-2021-00486
• Device Sequence Number: 5647728
• Product Code: HTY
• UDI-Device Identifier: 07613327096170
• UDI-Public: 07613327096170
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143063
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown