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

Catalog Number 511.801

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

(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 additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

This is event 2 of 2 of the same event.It was reported from (b)(6) that during an unspecified veterinary orthopedic surgical procedure, it was observed that the compact air drive device and the oscillating saw attachment device were stuck together.It was not reported if there were any delays to the surgical procedure or if a spare device was available for use.There was no human patient involvement as the devices were used in veterinary procedures.There were no 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

The date device returned to manufacturer was documented as 5/3/2018 in the previous report and has been updated as 5/23/2018.Additional information: during further follow-up the reporter mentioned that there was a forty five minute delay to the procedure.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.During repair, it was determined that the device had unknown debris substances on the internal sub-assemblies, the knob would not rotate; it was corroded and seized to the straining complete, the pin was broken off the set screw and there was an unknown substance on the eccentric bearing complete and ball bearings.The device also failed pretest for quick coupling for saw blades check-can¿t rotate the knob and the free moving check- coupling shaft seized.The assignable root cause was determined to be due to wear from normal use and servicing and improper cleaning.Additionally, a review of the device history was performed and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: OSCILLATING SAW ATTACHMENT II
• Type of Device: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7435596
• MDR Text Key: 105761956
• Report Number: 8030965-2018-53149
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 7611819102262
• UDI-Public: (01)7611819102262(11)071019
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• 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: 05/23/2018
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1