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

Catalog Number 532.021

Device Problems Device Operational Issue (2914); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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 that during an unspecified veterinary surgical procedure, it was discovered that the sagittal saw attachment device did not have any movement when connected to the drill device.It was further reported that it appeared one of the three buttons were stuck.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 reported as this was a veterinary procedure.There were no reports of 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.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.A visual and functional assessment was performed which found that the device was not functioning and was frozen.It was determined that one of the pins from the positioning ring was pushed in.It was further determined that the device failed for verify if secured with pin.It was noted that the failure associated with not secured with pin; required an update (but did not fall apart).During repair, it was observed that the device had a corroded needle sleeve.It was observed that the device had old, dirty grease and an unknown substance was inside the attachment device.It was determined that the issues were consistent with normal wear and improper cleaning.It was further determined that the pin issue was due to manufacturing issues.The assignable root causes were determined to be due to normal wear, improper cleaning and manufacturing issues.The manufacturing issue has been escalated to capa.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: SAGITTAL SAW ATTACHMENT
• 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: 7378200
• MDR Text Key: 103730854
• Report Number: 8030965-2018-52502
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819107182
• UDI-Public: (01)7611819107182(11)100914
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 532.021
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1