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

Catalog Number 19102000

Device Problems Device Emits Odor (1425); Smoking (1585); Sparking (2595)

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

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Sonicanchor generator sparked and smoked and there was a burning smell after it was turned on.

Manufacturer Narrative

Referring to the product inquiry the ultrasonic generator sonicpin is the only reported device and thus considered the primary product.A review of the device history records for the reported generator revealed no discrepancies; the item was documented faultless prior to distribution.According to the statement of the sales rep the generator was ¿used¿ at the time of the reported event.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 endoscopy ¿ (b)(4)) for examination and inspection in terms of function, assembly errors and review of the dhr.Inspection results (provided by stryker endoscopy, (b)(4) on (b)(4) 2016): ¿console does not power on.No assembly issues seen.Burnt components on main board.No missed steps on dhr.¿ in addition, on (b)(4), the following ¿investigation notes¿ by the manufacturing site stryker endoscopy, (b)(4), were submitted to stryker (b)(4): ¿does not power on, burnt component c424 and c423¿.Moreover, following ¿investigation notes¿ from vp (versatile powers / subsupplier for the mainboards of the consoles), where the generators have been inspected, as well, have been submitted by stryker endoscopy: ¿major arcing in both the pfc and bias section of the pcb.White fibers as well as some black residue.White material around burnt capacitor.¿ stryker endoscopy further stated: ¿all consoles were found with their warranty seal broken.Black and white residue was found on most boards.This residue is from an external source and not from the board itself.¿ to date it is not clear who has broken the seals.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: ¿the burning on the circuit is caused by multiple hipot testing.Hipot testing is used to verify electrical insulation by applying high voltage.Repetitive hipot testing, due to consoles moving around from one hospital to another, could lead to components weakening.¿ the project manager r&d sonic fusion platform stated: ¿biomed testing [¿hipot testing¿] is routine for all electrical devices entering the hospital.The test (acc din en 62353) consists of: current leakage test (if there is any current leaking to parts of the device unintended).Ground test (if the current can be deducted).Insulation impedance (if the insulation barrier is ¿high enough¿ to protect the current).The electronic components do underlie some wear as they are micro-damaged by every high-voltage application in the biomed testing.This sums up over time (multiple applications of biomed tests) and lead to failure of components / circuit.We do not anticipate the same ¿wear¿ effect by normal usage (at normal working electrical parameters).¿ based on the above observations the root cause of the reported event is eventually considered design related; the design may not be adequate for extensive biomed testing.Multiple hipot testing (due to consoles moving around from one hospital to another) could lead to components weakening.Further measures regarding this issue are covered by nc # 1298432 / capa # (b)(4).

Event Description

Sonicanchor generator sparked and smoked and there was a burning smell after it was turned on.

• 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: 5815298
• MDR Text Key: 51036936
• Report Number: 0009610622-2016-00358
• 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: 06/24/2016

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: 15J046714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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
• Patient Outcome(s): Other