MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS RADIOLUCENT-DRIVE MARK II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 511.300

Device Problem Poor Quality Image (1408)

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

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported when using the radiolucent drive under x-ray light, the operational area was not clearly visible.Customer reported "view as if metal was visible in the body".It is unknown if there was patient involvement during this event.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.(b)(6).The 510k#: device is not distributed in the united states, but is similar to device marketed in the usa.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.Additional narrative: service history review of the device has been performed.The review indicates that the device has not been serviced during the past 6 months.There is no information relevant to the current complaint issue.The investigation is based on the service & repair record (srr) 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.The service technician noted the following action taken: repair.The device has been serviced and functional testing has been performed in accordance with the service & repair procedure se_037288.During the pre-repair diagnostic assessment the service technician identified the following failure: coupling tool side worn out.The probable root cause of the event was determined to be normal wear.The device was repaired and returned to the customer if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RADIOLUCENT-DRIVE MARK II
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 3953723
• MDR Text Key: 4611958
• Report Number: 3009450871-2014-10275
• Device Sequence Number: 1
• Product Code: HWE
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2003
• 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