MAUDE Adverse Event Report: STRYKER GMBH SONICFUSION¿ ULTRASONIC GENERATOR SONICPIN®; PIN, FIXATION, SMOOTH

Catalog Number 19102000

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "it would not pass the starting test.".

Manufacturer Narrative

Please note correction to d9/h3: "product available to stryker" was changed to "no" (device disposition unknown).The device has been sent for an examination by the producer stryker endoscopy, san josé (ca), t&e does neither have the equipment nor the electronics specialists for a comprehensive inspection of the generator.Product assessment center: the reported event could not be confirmed, since the device was not available at engineering site for physical evaluation and no other evidence was provided at the time of primary investigation closure.Review of fedex tracking history revealed that the item was received on 9/26/2.023 at san josé, ca us.However, at the time of investigation closure the product destination was unclear and a physical evaluation impossible [it was considered as lost].Finally, it was pointed out that this issue needs to be addressed for root cause analysis as defined per local and /or global procedures.As per decision it was decided that an nc will be raised to the ownership of stryker endoscopy, san josé (ca).Review of capa database and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated non-function was addressed adequately.The file will be closed formally in accordance to our procedures.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.H3 other text : device disposition unknown.

Event Description

As reported: "it would not pass the starting test.".

• Brand Name: SONICFUSION¿ ULTRASONIC GENERATOR SONICPIN®
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17839799
• MDR Text Key: 324533364
• Report Number: 0009610622-2023-00337
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07613252495079
• UDI-Public: 07613252495079
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 19102000
• Device Lot Number: 15J046924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1