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

Catalog Number 1910-2602S

Device Problem Activation Failure (3270)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device remains implanted in the patient.

Event 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.".

Event 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.".

Manufacturer Narrative

Correction - please refer to h6 clinical code.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 was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: SONICPIN
• 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: 17676630
• MDR Text Key: 322623294
• Report Number: 0008031020-2023-00335
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613327336245
• UDI-Public: 07613327336245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170418
• 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: 11/03/2023

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 Catalogue Number: 1910-2602S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 09/04/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 49 YR
• Patient Sex: Female