MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN VITOSS BBTRAUMA FOAM PACK 5CC; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE

Catalog Number	2102-2205
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	08/29/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an expired 5cc product was used in a surgery.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: device history review indicated all devices accepted into final stock met specifications.Device inspection could not be performed as the reported device was not returned.Conclusion: the likely root cause of the reported event was determined to be user error.
Event or Problem Description
It was reported that an expired 5cc product was used in a surgery.

• Brand Name: VITOSS BBTRAUMA FOAM PACK 5CC
• Common Device Name: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 5966041
• Report Number: 0002530131-2016-00016
• Device Sequence Number: 19000646
• Product Code: MQV
• UDI-Device Identifier: 00808232001334
• UDI-Public: (01)00808232001334
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2017

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 Expiration Date: 07/31/2017
• Device Catalogue Number: 2102-2205
• Device Lot Number: B1407026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2016
• Supplement Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1