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

Catalog Number 19102000

Device Problem Fire (1245)

Patient Problem No Information (3190)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

While setting up a demo he plugged it in and hit the power button.It began to smoke and a flame came out.

Manufacturer Narrative

Referring to the product inquiry the ultrasonic generator sonicpin is considered the primary product.No further associated products were reported.A review of the device history records for the reported generator revealed no discrepancies; the item was documented faultless prior to distribution.Although pms-kiel is the official product assessment center (pac), pms t&e does neither have the equipment nor the electronics specialists for a comprehensive inspection of the generator.Thus, the affected console was sent to the supplier (stryker (b)(4)) for examination and inspection in terms of function, assembly errors and review of the dhr.According to the ¿non-conforming products - supplier investigation request form (sir)¿ filled by stryker endoscopy the root cause of malfunction for the reported generator is defined as follows: ¿root cause of failures: a previously investigated generator (¿) had the same components damaged, supplier is unable to determine the root cause of both generators.Due to the fact that the chassis was found dented which indicates that the generator must have been mishandled, the cause has been identified to be mishandling of the generator.¿ furthermore, stryker endoscopy stated: ¿generator was found with the warranty seal broken.Black residue was found on the main board.This residue is most likely from an external source and not from the board itself.¿ based on the above observations the root cause of the reported event is not linked to a deficiency of the device but is rather considered user related.(b)(4) was initiated because ¿sonicfusion ultrasonic generators failed during use; five complaints have been filed within a short time period (between (b)(6) 2016) regarding electronic problems such as frozen displays¿ (original nc description).(b)(4) has led to capa # (b)(4) in which several generators were involved.Different root causes have been identified, in some cases the root cause was considered ¿sales rep and or staff not aware of console`s sensitivity¿.This complaint was submitted approx.2 months after capa # (b)(4) was created.In this case no nonconformity was identified.

Event Description

While setting up a demo he plugged it in and hit the power button.It began to smoke and a flame came out.

• 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6149521
• MDR Text Key: 61920804
• Report Number: 0009610622-2016-00605
• Device Sequence Number: 1
• Product Code: HTY
• 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: 03/24/2017

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: Other
• Device Catalogue Number: 19102000
• Device Lot Number: 12K016374
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2012
• 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
• Patient Outcome(s): Other