MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS AIR PEN DRIVE; MOTOR, DRILL, PNEUMATIC

Catalog Number 05.001.080

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

It was reported that air escapes when the device is connected to the air hose, causing the device to lose performance.This event happened during an operation.A spare device was used, and there were no delays in surgery and the patient was not affected.The report also stated that the device was sent in for evaluation & repair.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Without a lot number the device history records review could not be completed.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.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.(b)(4).Service history review of the device has been performed.The review indicates that the device has not been serviced during the past six months.There is no information relevant to the current complaint issue.(b)(6).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: the investigation is based on the service & repair record received.The device failure reported by the customer could be confirmed.The service history review shows no previous service conditions relevant to the current complaint issue.After pre-repair diagnostic assessment, the device has not been serviced.The service technician noted the following action maintenance and inspection.During the pre-repair diagnostic assessment the service technician identified the following failure: motor blocked, seized, rough running.The root cause of the event was determined to be normal wear.The device was repaired and returned to the customer.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.

• Brand Name: AIR PEN DRIVE
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH44 37; SZ CH4437
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; hauptstrasse 24; waldenburg CH44 37; SZ CH4437
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3767634
• MDR Text Key: 4377074
• Report Number: 3009450871-2014-10108
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 05.001.080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2010
• 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