MAUDE Adverse Event Report: STRYKER GMBH SONICPIN; PIN, FIXATION, SMOOTH

Catalog Number	1910-2602S
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device discarded by user.
Event or Problem Description
As reported: "surgeon states that both 26mm sonic pins did not fully liquify when the ultrasonic energy was applied.Surgeon stated the pins liquefied distally and proximally but not at the center aspect.Surgeon stated this happened twice in a row with the 26mm pins.Surgeon removed the first 26mm pin but allowed the 2nd 26mm pin to remain in the patient after she removed some of the head.The surgeon used a 22mm pin right after and stated she had no issue with the 22mm pin fully liquefying.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.As no deviation was reported during the test set-up which is required per labelling and the fact that the counterpart [generator] was successfully liquifying another pin in the end it could not be excluded that it is rather related to a sub-optimal intraoperative procedure.The labelling points out that ¿if the bioresorbable pin is not correctly placed to cross the osteotomy line, the liquification process will be compromised.Consequently, the fixation will be compromised.¿ finally, 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
As reported: "surgeon states that both 26mm sonic pins did not fully liquify when the ultrasonic energy was applied.Surgeon stated the pins liquefied distally and proximally but not at the center aspect.Surgeon stated this happened twice in a row with the 26mm pins.Surgeon removed the first 26mm pin but allowed the 2nd 26mm pin to remain in the patient after she removed some of the head.The surgeon used a 22mm pin right after and stated she had no issue with the 22mm pin fully liquefying.".

• Brand Name: SONICPIN
• 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: 17676609
• Report Number: 0008031020-2023-00334
• Device Sequence Number: 6256941
• Product Code: HTY
• UDI-Device Identifier: 07613327336245
• UDI-Public: 07613327336245
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K170418
• 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): 10/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2024
• Device Catalogue Number: 1910-2602S
• Device Lot Number: 1000524945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 09/04/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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 Age: 49 YR
• Patient Sex: Female