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

Catalog Number	2090-9029
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/24/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the two needles bent upon insertion.
Additional 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 or Problem Description
It was reported that the two needles bent upon insertion.

• Brand Name: VITOSS BONE MARROW NEEDLES 8G X 6
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 5514512
• Report Number: 0002530131-2016-00007
• Device Sequence Number: 356973
• Product Code: KNW
• UDI-Device Identifier: 07613327123562
• UDI-Public: (01)07613327123562
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2016

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
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2016
• Supplement Report FDA Received Date: 06/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1