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

Model Number	CHRIS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; needle bent in pedicle and could not remove.Couldn't put a screw in the pedicle where needle got stuck.Sales rep reported surgery was completed by skipping that level.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: device evaluation indicated; the returned device was missing its top green handle.The device showed light scratches all throughout.The distal tip is noted to be slightly bent likely due to contact with a hard surface.Conclusion: 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 needle could have contributed to the bending of the needle.Therefore; the likely root cause is multifactorial.
Event or Problem Description
It was reported that; needle bent in pedicle and could not remove.Couldn't put a screw in the pedicle where needle got stuck.Sales rep reported surgery was completed by skipping that level.

• Brand Name: VITOSS BONE MARROW NEEDLES FENESTRATED 8G X 6
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 5448661
• Report Number: 0002530131-2016-00003
• Device Sequence Number: 325034
• Product Code: KNW
• UDI-Device Identifier: 07613327123579
• UDI-Public: (01)07613327123579
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 11/30/2018
• Device Model Number: CHRIS
• Device Catalogue Number: 2090-9030
• Device Lot Number: T1511008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2016
• Supplement Report FDA Received Date: 05/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR