MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN VITOSS BONE MARROW NEEDLES 8G X 6; BIOPSY INSTRUMENT

Catalog Number 2090-9029

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 02/24/2016

Event Type  malfunction  

Event Description

It was reported that the two needles bent upon insertion.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: device history review indicated all devices accepted into final stock met specifications.Per sales rep, the reported device was hammered with normal force and patient's bone quality was normal.The patient's bone quality, the motion used when inserting the needle, the force used during insertion and/or force used during removal of the reported needles could have contributed to the bending of the needle.Conclusion: the likely root cause of the reported event is multifactorial.

Event Description

It was reported that the two needles bent upon insertion.

• Brand Name: VITOSS BONE MARROW NEEDLES 8G X 6
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5514512
• MDR Text Key: 41049116
• Report Number: 0002530131-2016-00007
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 07613327123562
• UDI-Public: (01)07613327123562
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2090-9029
• Device Lot Number: T1511005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1