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

Catalog Number 19102000

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During primary foot procedure (side unknown).It was reported that the sonic generator gave an error (l01000 lockdown error).The patient had been under anesthesia for approximately 5 minutes before the case was cancelled.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be the main board or front board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.It could not be determined if the housing / cover had become damaged by accident.According to the location and to the kind of damage high external forces had been significantly applied.Review of complaint history, capa database and risk analysis performed by pac did not identify any discrepancies.The review of the risk assessment for the failure mode 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.For transport handling (¿sales rep and or staff not aware of console`s sensitivity¿) nc (b)(4) (closed) and nc (b)(4) (in process) are in place.According to received information a specific root cause was not defined.A damaged cover can only be caused by unsuitable handling which is regarded as user / customer related.

Event Description

During primary foot procedure (side unknown).It was reported that the sonic generator gave an error (l01000 lockdown error).The patient had been under anesthesia for approximately 5 minutes before the case was cancelled.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: SONICFUSION ULTRASONIC GENERATOR SONICPIN®
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7452039
• MDR Text Key: 106388230
• Report Number: 0009610622-2018-00183
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: K091955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2018

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: K0A913F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 07/10/2018
• Supplement Dates FDA Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other