MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS OSCILL-SAW-ATTACHM F/532.001 532.010 532; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 532.021

Device Problems Partial Blockage (1065); Mechanical Problem (1384); Physical Resistance (2578); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.An assessment was performed on the device which determined the mechanics swing fork was blocked.It was further noted that the mechanics seized, jammed and were heavy moving.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from (b)(6) that the oscillating saw attachment device was jammed.The reporter stated there was an issue with the bearing of the device.During in-house engineering evaluation it was found that the mechanics swing fork was blocked and the mechanics 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 to 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: OSCILL-SAW-ATTACHM F/532.001 532.010 532
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5201853
• MDR Text Key: 30694654
• Report Number: 3009450871-2015-14024
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2015

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: 532.021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2014
• 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