MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BONE COLLECTOR; BONE PARTICLE COLLECTOR - BONE COLLECTOR

Catalog Number B-COLLECTOR-1

Device Problems Break (1069); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device product code is mxp.The actual device was returned and is currently pending evaluation.Once reliability engineering evaluates the device, a follow-up medwatch will be submitted.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 4 of 7 for the same event.It was reported that the packaging of the seven bone collector devices were damaged and the devices inside each packaging were broken.According to the report, the shipping box was undamaged.The event was not reported to have occurred during surgery.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.There was no patient involvement.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

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the packaging of all seven bone collectors were found to be completely crashed.Therefore, the reported condition was confirmed.It was determined that the packaging was ran over by heavy cart wheels or squeezed between two surfaces at the customer site as all seven bone collectors inside were crashed.The assignable root cause was determined to be due to misuse / abuse and possibly user error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BONE COLLECTOR
• Type of Device: BONE PARTICLE COLLECTOR - BONE COLLECTOR
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 4934081
• MDR Text Key: 22646412
• Report Number: 1045834-2015-11666
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-COLLECTOR-1
• Device Lot Number: J133104571
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1