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

Catalog Number UNK_PRODUCT

Device Problems Difficult to Remove (1528); Sticking (1597); Temperature Problem (3022)

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

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the brand name, common device name are unknown the manufacturing location is unknown.The catalog number, lot/serial number is unknown.Device manufacture date: the device manufacture date is unavailable.(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 2 of 3 for the same event.It was reported from sweden that during an unspecified surgical procedure, it was observed that the electric pen drive device and the burr attachment device were getting warm.It was further reported that the burr device could not be removed from the attachment device after the surgery while preparing for cleaning at the operating room.It was unknown when the burr device got stuck in the attachment device.There was an unspecified amount of delay to the surgical procedure.It was unknown if a spare device was available for use.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.

• Brand Name: UNKNOWN ELECTRIC PEN DRIVE DEVICE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; n/i; n/i
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6113353
• MDR Text Key: 60856633
• Report Number: 8030965-2016-15630
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 11/18/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ATTACHMENT DEVICE; BURR DEVICE