MAUDE Adverse Event Report: STRYKER GMBH SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #2 / C-7; PIN, FIXATION, SMOOTH

Catalog Number	1910-1273S
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Sonic anchors failed to "melt" properly.The first anchor attempted to melt, but the following two anchors did not melt at all.No error message was displayed on the generator.After the first two failed, we disconnected the machine, attached a new tip, then reconnected the machine.No error message displayed either times.The surgery was completed in an old school.No anchors were implanted.
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event that sonicanchor kit 2.5x10 mm / force fibre #2-0 / c-2 was alleged of implant ¿ activation failure could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Per event reported ¿the first anchor attempted to melt, but the following two anchors did not melt at all¿ and as per corresponding labelling under the section ¿troubleshooting & error codes¿ it is pointed out for ¿the electrical interference is sporadic¿ to perform following steps: power down all electrical equipment not in use.Increase distance of other electrical equipment.Connect the unit and other equipment into different outlets.As an accessories change and reboot of generator was performed it could also not be excluded that the event reported was related to other electrical equipment and/or outlets used.However, a check of the whole construct and performing test set-up was impossible since not made available for evaluation.Therefore, a further technical statement could not be given, and a real root cause could not be verified.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.
Event or Problem Description
Sonic anchors failed to "melt" properly.The first anchor attempted to melt, but the following two anchors did not melt at all.No error message was displayed on the generator.After the first two failed, we disconnected the machine, attached a new tip, then reconnected the machine.No error message displayed either times.The surgery was completed in an old school.No anchors were implanted.

• Brand Name: SONICANCHOR KIT 2.5X10 MM / FORCE FIBRE #2 / C-7
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19488148
• Report Number: 0009610622-2024-00271
• Device Sequence Number: 17933161
• Product Code: HTY
• UDI-Device Identifier: 07613327096149
• UDI-Public: 07613327096149
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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 Expiration Date: 01/10/2025
• Device Catalogue Number: 1910-1273S
• Device Lot Number: 1000550419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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: Male