MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK DIRECTINJECT ON DEMAND HA CEMENT; IMPLANT

Model Number	79-45903
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by the health professional that during the surgery it was noticed the syringe was broken.
Additional Manufacturer Narrative
The complained product was returned for investigation.The product return included the syringe 2 cannulas and the inner packaging in which all parts of the product were originally delivered.Just one of the cannulas were used.
Event or Problem Description
It was reported by the health professional that during the surgery it was noticed the syringe was broken.

• Brand Name: DIRECTINJECT ON DEMAND HA CEMENT
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; IE NA
• MDR Report Key: 9764755
• Report Number: 0008010177-2020-00012
• Device Sequence Number: 2910602
• Product Code: GXP
• UDI-Device Identifier: 07613327123371
• UDI-Public: 07613327123371
• Combination Product (Y/N): N
• PMA/510(K) Number: K143661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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: Health Professional
• Device Model Number: 79-45903
• Device Catalogue Number: 79-45903
• Device Lot Number: DI19233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1