MAUDE Adverse Event Report: DEPUY MITEK 422-1 HCL STRYKER FOMULA/12K -NS; FMS EQUIPMENT SYSTEMS

Catalog Number 282001

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Surgical procedure, delayed (2565)

Event Date 02/18/2015

Event Type  Injury  

Event Description

The sales rep reported that during the shoulder procedure, the pump stopped reading the shaver, so they had to switch over to the stryker device which took 20 minutes, and in the midst of the procedure, it took another 20 minutes to then switch over to the mitek device.The sales rep reported that the mitek device was not on site so the stryker was used until they got another mitek shaver.The sales rep reported that in all the procedure was delayed 40 minutes, where the patient was under anesthesia.It was reported that the procedure was completed and there were no patient consequences.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore, depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.Awaiting return.

Manufacturer Narrative

The complaint device has not been returned, despite requesting it several times, therefore unavailable for a physical evaluation.This device is a legacy fms device; therefore a lot review is not needed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.

Event Description

The sales rep reported that during the shoulder procedure the pump stopped reading the shaver, so they had to switch over to the stryker device which took 20 minutes, and in the midst of the procedure it took another 20 minutes to then switch over to the mitek device.The sales rep reported that the mitek device was not on site so the stryker was used until they got another mitek shaver.The sales rep reported that in all the procedure was delayed 40 minutes, where the patient was under anesthesia.It was reported that the procedure was completed and there were no patient consequences.

• Brand Name: 422-1 HCL STRYKER FOMULA/12K -NS
• Type of Device: FMS EQUIPMENT SYSTEMS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: bahaa nashed ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4584043
• MDR Text Key: 5343525
• Report Number: 1221934-2015-00649
• 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: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 282001
• Device Lot Number: 257367-3110
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2015
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other