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

Model Number	2102-2205
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hospital used expired product.It was reported that a package of expired bbt was used on a patient.It was reported that the product had expiry date: september 30 2016.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment; result: 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.Complaint history review indicated there have been no other similar complaints for the reported lot.Conclusion: based on the reported event, the likely root cause of the reported event was determined to be user error.
Event or Problem Description
It was reported that the hospital used expired product.It was reported that a package of expired bbt was used on a patient.It was reported that the product had expiry date: september 30 2016.

• 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: 6578597
• Report Number: 0002530131-2017-00007
• Device Sequence Number: 16299803
• Product Code: MQV
• UDI-Device Identifier: 00808232001334
• UDI-Public: (01)00808232001334
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

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: 09/30/2016
• Device Model Number: 2102-2205
• Device Catalogue Number: 2102-2205
• Device Lot Number: B1409012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1