MAUDE Adverse Event Report: SYNTHES OBERDORF OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number 511.801

Device Problem Partial Blockage (1065)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event was unknown.(b)(6).The actual device was returned for evaluation.During engineering evaluation of the device it was determined that the gear blocked, seized and rough running.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.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 locking part on the oscillating saw attachment device was defective.During in-house engineering evaluation, it was observed that the gear blocked, seized and rough running.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: OSCILLATING SAW ATTACHMENT II
• Type of Device: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5155595
• MDR Text Key: 28885399
• Report Number: 8030965-2015-11666
• Device Sequence Number: 1
• Product Code: GFA
• 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: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2001
• 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