MAUDE Adverse Event Report: DEPUY MITEK LLC US 4176 FOOT PED BOARD 4WAY; FOOT-SWITCH, ELECTRICAL

Catalog Number	284176
Medical Device Problem Codes	Intermittent Loss of Power (4016); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The serial number is not currently available.(b)(4).Investigation summary: the complaint device is not being returned, multiples attempts for product return were made with no response, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.  no further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the affiliate in (b)(6) via email that during a shoulder arthroscopy with cuff suture procedure, it was observed that the shaver worked alone during the surgery.According to the report, the sales rep thought the problem was in the handpiece and she made the exchange.However, the problem remained during the surgery.In addition, she realized that the device worked only when it was placed on the patient, she identified several times the doctor using the shaver without having to step on the pedal.The vapr also had a problem, in the middle of the surgery it stopped working, turned it off and turned it on and the product continued to present a problem.Consequence: the doctor chose to end the open surgery.It was not reported if there was a delay in the surgical procedure or if a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.This complaint involves two (2) devices.

• Brand Name: 4176 FOOT PED BOARD 4WAY
• Common Device Name: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9069531
• Report Number: 1221934-2019-58324
• Device Sequence Number: 14220400
• Product Code: HRX
• UDI-Device Identifier: 10886705017256
• UDI-Public: 10886705017256
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 284176
• Device Lot Number: E03AX1047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention