MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SONICFUSION ULTRASONIC GENERATOR SONICPIN; PIN, FIXATION, SMOOTH

Model Number	1910-2000
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "this was our second sonic anchor case of the day.Our first sonic anchor case went perfectly and the machine was functioning fine.During our second case, the machine's touch screen stopped working.The screen would not let me advance to the test screen.Basically when you would touch the screen, nothing would happen.Since we could not advance to the test screen, we were not able to use the sonic anchor implant." additionally reported: delay was "10-15 minutes trying to troubleshoot", competitor device "mitek suture anchor" was implanted instead.
Additional Manufacturer Narrative
The device was examined by the producer stryker endoscopy, san josé (ca) as the official product assessment centre (pac).Visual inspection: the console was received with the warranty seal broken.Also labels were noticed externally.Functional inspection confirmed no function, due to the fact the touchscreen being frozen.Review of complaint history, capa database and risk analysis performed by pac did not identify any conspicuity.The review of the risk assessment indicated potential non-function was addressed adequately.There were no actions in place related to the reported event for the subject product.A review of the change history revealed the item in question had been manufactured according to current design version.However, no further information is available that would aid in determining a root cause of this occurrence.A broken warranty seal is regarded as user / customer related.
Event or Problem Description
As reported: "this was our second sonic anchor case of the day.Our first sonic anchor case went perfectly and the machine was functioning fine.During our second case, the machine's touch screen stopped working.The screen would not let me advance to the test screen.Basically when you would touch the screen, nothing would happen.Since we could not advance to the test screen, we were not able to use the sonic anchor implant." additionally reported: delay was "10-15 minutes trying to troubleshoot".Competitor device "mitek suture anchor" was implanted instead.

• Brand Name: SONICFUSION ULTRASONIC GENERATOR SONICPIN
• Common Device Name: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9954496
• Report Number: 0009610622-2020-00144
• Device Sequence Number: 2817463
• Product Code: HTY
• UDI-Device Identifier: 07613252495079
• UDI-Public: 07613252495079
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091955
• 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): 08/14/2020

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: 1910-2000
• Device Catalogue Number: 19102000
• Device Lot Number: 17J577874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1