MAUDE Adverse Event Report: SYNTHES OBERDORF FOOT PEDAL FOR PIEZOELECTRIC SYSTEM; INSTRUMENT, SURGICAL, SONIC ACCESSORY, ATTACHMENT

Catalog Number 05.001.402

Device Problems Unintended Power Up (1162); Unintended Movement (3026)

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

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot or serial number, a service history record review could not be completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the foot pedal will not stop running unless it is unplugged and plugged back in again.The hand piece reads as "no detected" on the console.The complained issued occurred happened intraoperatively; however, the device was not used on the patient and there was no surgical delay.This report is 3 of 3 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the service history records has been requested.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.

Manufacturer Narrative

A service & repair history review was performed.The investigation of the complaint articles indicates that the: service history review: part no: 05.001.402, serial/lot no: (b)(4).A service history of the past three years has been reviewed.No service history review can be performed.The item has not previously been in for service.There is no information relevant to the current complained issue.The manufacture date of this item is 26-jul-2011.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.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.

Manufacturer Narrative

Device 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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A service and repair evaluation was performed for the subject device.The customer reported the foot pedal was running continuously.The cause of the issue is unknown.The device was sent to the vendor for repair on 15-oct-2015.The vendor determined that the foot pedal had an internal issue, which required replacement of the device.The item was be forwarded to the synthes complaint handling unit (chu) upon completion of service and repair process for additional evaluation.The evaluation was confirmed.Additional investigation was performed for the subject device by the synthes chu.The foot pedal (05.001.402 lot 700780.021) is a component of the piezoelectric system set (01.001.598) and provides real-time hands-free adjustment of the handpiece during surgery per the technique guide.The foot pedal is comprised of five buttons, each of which performs difference functions: handpiece control, flush/prime irrigation, change program, select left or right handpiece, irrigation on/off.A definitive root cause was unable to be determined; the failure mode is likely related to rough handling and/or wear over 4+ years of use (manufacturing date june 2011).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: FOOT PEDAL FOR PIEZOELECTRIC SYSTEM
• Type of Device: INSTRUMENT, SURGICAL, SONIC ACCESSORY, ATTACHMENT
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf PA CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5051166
• MDR Text Key: 24892470
• Report Number: 2520274-2015-15651
• Device Sequence Number: 1
• Product Code: JDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup,Followup,Followup
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.402
• Device Lot Number: 700780.021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2011
• 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