MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC OSCILL-SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 518.010

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the oscillating saw device did not work.It was not reported if there was a delay in the procedure due to the event, or if there was a spare device available for use.It was reported that the procedure was successfully completed.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device was evaluated and the reported condition that the device did not work was confirmed.An assessment was performed and it was observed that the motor power was too weak.It was noted that the motor was too weak.It was further determined that the device failed pretest for check performance, check oscillation frequency, and check the tool coupling.A review of the service history record indicates that the device had been returned previously for the same malfunction.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.

• Brand Name: OSCILL-SAW
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7651430
• MDR Text Key: 112861556
• Report Number: 8030965-2018-54722
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819037069
• UDI-Public: (01)7611819037069(11)001207
• Combination Product (y/n): N
• PMA/PMN Number: K971544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

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: 518.010
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1