MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC DOUBLE AIR HOSE, 3M, FOR AIR PEN DRIVE; MOTOR, DRILL, PNEUMATIC

Catalog Number 05.001.083

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: the device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to component failure from normal wear.The manufacturing location was unknown.Udi: (b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the air hose device had ruptured and had component damage.It was further determined that the device failed pretest for check outer hose and general condition.This event did not occur during surgery.There was no patient involvement.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.

• Brand Name: DOUBLE AIR HOSE, 3M, FOR AIR PEN DRIVE
• Type of Device: MOTOR, DRILL, PNEUMATIC
• 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: 10535432
• MDR Text Key: 207020858
• Report Number: 8030965-2020-06382
• Device Sequence Number: 1
• Product Code: HBB
• UDI-Device Identifier: 07611819831520
• UDI-Public: 07611819831520
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K093361
• 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: 08/14/2020

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: 05.001.083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/15/2020
• Date Device Manufactured: 07/22/2008
• 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