MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AVAFLEX BALLOON 10G 15MM; ARTHROSCOPE

Catalog Number	AFB1015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the while removing the needle to inject more cement, the cement hardened and the needle broke off in the patient.There was a clinically significant medical delay as the patient was taken to the operating room to remove the device material left behind.A portion of the device was left in the patient.No additional adverse consequences were reported.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.Discarded.
Event or Problem Description
It was reported that the while removing the needle to inject more cement, the cement hardened and the needle broke off in the patient.There was a clinically significant medical delay as the patient was taken to the operating room to remove the device material left behind.A portion of the device was left in the patient.No additional adverse consequences were reported.

• Brand Name: AVAFLEX BALLOON 10G 15MM
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7702434
• Report Number: 0001811755-2018-01175
• Device Sequence Number: 10950607
• Product Code: HRX
• UDI-Device Identifier: 10885403223259
• UDI-Public: 10885403223259
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162062
• 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): 11/30/2018

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: Health Professional
• Device Catalogue Number: AFB1015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1