MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BURR-ATTACHM MEDIUM F/EPD+APD; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESSORIES AND ATTACHMENT

Catalog Number 05.001.046

Device Problems Unstable (1667); Mechanical Jam (2983); Positioning Problem (3009)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the bearing seized,jammed and heavy moving.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to normal wear.If information is obtained that was not available for the initial medwatch, a supplemental medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that the attachment device could not be positioned when mounted to a device.According to the reporter the part was out of balance and could not be used.Durin in-house engineering evaluation, it was observed that the bearings seized, jammed and were heavy moving.It was not reported if the device was used in surgery, or if there was patient involvement.There were no delays in a scheduled surgical procedure.A spare device was not available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BURR-ATTACHM MEDIUM F/EPD+APD
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESSORIES 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5198713
• MDR Text Key: 30569861
• Report Number: 3009450871-2015-14014
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK043310
• 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
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2014
• 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