MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC IRRIGATION TUBE SET SINGLE PACK STERILE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.178.01S

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device manufacture date: the device manufacture date is unavailable; (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 1 of 2 for the same event.It was reported that during an unspecified surgical procedure, it was observed that the white attachment to the tubing which goes into the saline bag was not attached well and not tightened causing it fall off and no longer maintain a sterile line to the saline of the irrigation tube set device.According to the report, this event was observed at the beginning of the procedure.It was furher reported that during the same procedure, when using a second irrigation tube set device, it was observed that the white part fell off when inserting it into the saline bag.The reporter stated that the clear luer lock end of the tubing which connects to the white cannula spike may have been the issue.It was reported that when the two parts were connected, the connection seemed to be loose and luer lock did not have enough threads to grab and secure to the white spike.It was reported that there was no delay in the procedure due to the event.It was reported that a spare device was available for use and the procedure was completed successfully.There was patient involvement reported.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The previous report stated the date of manufacture (dom) was unknown.The dom has been updated to reflect the date (jun 5, 2017) the device was manufactured.The udi has been updated accordingly.The actual device was returned for evaluation.The device was evaluated and the reported condition was not confirmed.An assessment was performed and the device met all manufacture's specifications.Therefore, an assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.It was documented in the previous supplemental report that the date of manufacture (dom) was jun 5, 2017.The dom has been updated to reflect the correct date (dec 8, 2017) the device was manufactured.The udi has been updated accordingly.The manufacturing site name was documented as (b)(4) in the initial report.This has been updated to (b)(4).Please note that the contact office name/address have been updated accordingly to reflect the corrected manufacturing facility.If additional information should become available, a supplemental medwatch will be submitted accordingly.It was inadvertently documented in the initial medwatch report that the manufacturing location was (b)(4).Please note that the manufacturing site location is unknown.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: IRRIGATION TUBE SET SINGLE PACK STERILE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; eimattstrasse 3; oberdorf FL 4436 ; SZ 4436
• Manufacturer (Section G): N/I; n/i; n/i FL
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7348271
• MDR Text Key: 102738850
• Report Number: 1045834-2018-50541
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2018

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: 05.001.178.01S
• Device Lot Number: L619174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 04/04/2018; 05/08/2018
• Supplement Dates FDA Received: 04/10/2018; 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2017
• 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