MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN ALLOGRAFT EVANS WEDGE 10X22X20MM; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE

Catalog Number 3102-1910

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

Method: impact assessment.Device not returned.Results: device not returned.The supplied impact assessment stated that based on the packaging and temperature requirements for the grafts, the movement of the grafts from one facility to another while maintained at room temperature for the stated time does not conflict with the labeled storage conditions.Conclusion: the investigation concluded this is a compliance issue with the proper handling process of tissue products and there is no device specific failure mode with the reported device.Implanted.

Event Description

It was reported that: protocol at medical center was not followed for proper transportation of bone wedge biologic graft.The representative physically brought in the graft from a different facility that had shipped in the morning of the incident.The graft should have been shipped in directly and not brought in from another facility.Update: on (b)(6) 2016; it was reported the graft was used in a patient.Furthermore, it was reported the patient is doing well and no adverse consequences have been reported.

Manufacturer Narrative

Method: risk assessment; results: there is no device specific failure mode identified with the reported device, the issue was with proper facility transfer protocol not being followed.Conclusion: the investigation concluded this is a compliance issue with the proper handling process of tissue products and there is no device specific failure mode with the reported device.

Event Description

It was reported that; protocol at medical center was not followed for proper transportation of bone wedge biologic graft.The representative physically brought in the graft from a different facility that had shipped in the morning of the incident.The graft should have been shipped in directly and not brought in from another facility.Update: on 27-jul-2016; it was reported the graft was used in a patient.Furthermore, it was reported the patient is doing well and no adverse consequences have been reported.

• Brand Name: ALLOGRAFT EVANS WEDGE 10X22X20MM
• Type of Device: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE
• 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: 5857780
• MDR Text Key: 52783084
• Report Number: 0009617544-2016-00324
• Device Sequence Number: 1
• Product Code: MBP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

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
• Device Operator: No Information
• Device Catalogue Number: 3102-1910
• Device Lot Number: 153193-1011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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