MAUDE Adverse Event Report: DEPUY MITEK 4580 FMS DUO+ PUMP/SHAVER COMBO; FMS PUMPS

Catalog Number 284580

Device Problem Insufficient Information (3190)

Patient Problem Shock (2072)

Event Date 06/20/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

In the completion of using the shaver blade in arthroscopic procedure omnispam, it gave shocks to the patient who was anesthetized.Even after checked all the connections and wires, exchanged the shaver handpiece, the material was still presenting problem.At the end of the procedure the two handpieces that were in the surgical field, they touched each other and got short-circuit, giving a great bursting and noise in the operating room.Immediately they turned off all the equipment and the surgeon finished the procedure.Even with the situation, the procedure was completed successfully and the meniscus was sutured satisfactorily.The local maintenance service will verify and repair the equipment (equipment division).The 20/06/2016 (field adviser aware) the 29/06/2016 (quality aware) did the event occur during a procedure/surgery- yes.Surgery type-arthroscopic procedure omnispam 1035.Is it a potential adverse event? yes.Potential local legal implications? no.Action user took to mitigate/ resolve problem during procedure - unknown.The affiliate responded with the following via email on (b)(6) 2016: please see below the answers received the sales rep.: was it electrical shocks to the patient, or did the surgeon hit a nerve resulting in patient movement? hock to the patient.Was the pump plugged into a grounded outlet? yes, the previous surgery was linked to concorrete pump and it worked without problems.Did any fuse or circuit breaker blow during this event? no.When the 2 shaver handpieces touched, what were they plugged into (were there 2 pumps in the room with one shaver plugged into each one)?  handpiece pump was turned off and the other was connected.Has the customer checked out their electrical setup in their operating room (or)? yes.Were there any adverse patient consequences? no.Is it one pump and 2 shaver handpieces being returned for evaluation and repair? according to mr.(b)(6) , mr.(b)(6) asked to send only shaver pump for verification since this department does not check the handpieces.What is the product code and serial number of the 2 shaver handpieces?  l001948.2 2pcs.The 1*pc 500009115, serial (b)(4)/ of equipment serial piece (b)(4).The 2*pc 500009116, serial (b)(4) / of equipment serial piece (b)(4).Information received via email from our affiliate on (b)(6) 2016: while we were trying to identify the correct code and lot, i sent to you an internal codes, that is why you could not recognize them, sorry.After checking, the correct code and lot for the two hand piece are: code.: 225002, hand piece vaprlot: 1412086.Producto jnj.Code: 50198381, hand piece shaver, lot: 1209, manufacturer: razek (not a jnj product).Was the sales rep / agent present during the event? yes.

Manufacturer Narrative

The complaint device was returned to a mitek authorized service center for evaluation.Visual and functional checks were performed.The service center could not duplicate the reported problem; this complaint could not be confirmed.A bent hinge, unrelated to the reported complaint, was replaced.The device passed all functional performance tests and required safety testing.A review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this serial number device that was released to distribution in 2013.The device was sent to a mitek service center for general service in december 2014 and passed functional and safety testing at that time.We cannot discern a root cause for the reported failure mode.One possible root cause is that as reported by the complainant, two locally sourced shaver handpieces were allowed to come in contact with each other during the procedure.No other information was provided on these shavers that could help determine the root cause of this failure.It is likely the electrically isolated tip or shaver blade of one of the customer¿s shavers came in contact with a grounded case of the second customer shaver resulting in the spark and noise reported by the complainant.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

• Brand Name: 4580 FMS DUO+ PUMP/SHAVER COMBO
• Type of Device: FMS PUMPS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 5828439
• MDR Text Key: 50620967
• Report Number: 1221934-2016-10302
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2016
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other