MAUDE Adverse Event Report: SYNTHES OBERDORF OSCILL-SAW-ATTACHM W/QUICK-COUPL F/COMPA; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number 511.801

Device Problem Device Inoperable (1663)

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

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Reporter's full name, complete address and phone number were not provided.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device was evaluated and it was determined that the coupling power supply of the attachment device was not functioning and was defective.It was noted that the coupling shaft was defective.It was further determined that the device failed pretest for check oscillation frequency, and check the machine coupling.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the attachment device became powerless.It was not reported if there was a delay in the procedure due to the event, or if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: OSCILL-SAW-ATTACHM W/QUICK-COUPL F/COMPA
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6980183
• MDR Text Key: 90950280
• Report Number: 8030965-2017-15836
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: EXEMPT
• 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: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• 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: 10/20/2017
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2015
• 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