MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS ELECTRIC PEN DRIVE 60,000 RPM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.010

Device Problem Device Stops Intermittently (1599)

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

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot/serial number is unknown.The manufacturing location was unknown.Device manufacture date is unknown.Reporter¿s complete name, address and phone number were not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

This is report 2 of 2 for the same event: it was reported from (b)(6) that during a partial mandibulectomy on a patient with a lower gingival carcinoma, it was discovered that the electric pen drive device and the cable device were suspected to have a loose connection.According to the report, the surgeon used a cutting burr device with the electric pen drive device to remove the lesion.However, during reconstruction surgery of the mandible, it was observed that the electric pen drive device did not work well and just stopped when the surgeon made a hole with a j-latch attachment.It was further reported that the surgeon thought that the device would work and stop depending on the attachment with the handpiece.It was not reported whether there were any delays and the surgery was completed with another device.There was patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The manufacturer location was documented as unknown in the initial report.The location has been updated to waldenburg.Contact office name/address has been updated accordingly to reflect the correct manufacturing facility.The device manufacture date was documented as unknown in the initial report.It has been updated to april 25, 2006.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.During subsequent follow-up, it was clarified that the pen drive device was working intermittently.It was also reported that it was suspected that the pen drive device cable and switch were malfunctioning.It was also reported that there was no allegation of malfunction against the attachments but when the customer used the j-latch for the pen drive device for drilling the pen drive device was stopping.It was further reported that the customer did not complain about the j-latch because the customer felt the function of the pen drive was irregular.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

• Brand Name: ELECTRIC PEN DRIVE 60,000 RPM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH443 7; SZ CH4437
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6080574
• MDR Text Key: 59561040
• Report Number: 2520274-2016-15161
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ATTACHMENT DEVICE; CABLE DEVICE; CUTTING BURR DEVICE