MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC DOUBLEAIRHOSE L3M F/SYST-SYNTHES; INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT

Catalog Number 519.510

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the double air hose device was leaking air.There were no delays in the surgical procedure as a spare device was available for use.It was reported that the surgical procedure was completed.There was patient involvement.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.

• Brand Name: DOUBLEAIRHOSE L3M F/SYST-SYNTHES
• Type of Device: INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf ; SZ
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA ; 6107195000
• MDR Report Key: 7067132
• MDR Text Key: 93240646
• Report Number: 8030965-2017-50146
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819037168
• UDI-Public: (01)07611819037168(11)161114
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 519.510
• Date Manufacturer Received: 10/31/2017
• Date Device Manufactured: 11/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1