MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC DOUBLEAIRHOSE L5M F/SYST SYNTHES; INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT

Catalog Number 519.530

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the hose device ruptured.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi ¿ (b)(4).

Event Description

It was reported from (b)(6).That during service and evaluation, it was determined that the hose device ruptured.It was further determined that the device failed pretest for check outer hose, and general condition.It was noted in the service order that the device was not working.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: DOUBLEAIRHOSE L5M F/SYST SYNTHES
• Type of Device: INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9266949
• MDR Text Key: 195946843
• Report Number: 8030965-2019-69771
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819037182
• UDI-Public: 7611819037182
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 519.530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Date Manufacturer Received: 10/21/2019
• Date Device Manufactured: 01/31/2019
• 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