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

Model Number 79-45903

Device Problem Fracture (1260)

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

Event Date 02/19/2020

Event Type  malfunction  

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 Description

It was reported by the health professional that during the surgery it was noticed the syringe was broken.

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 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
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; IE NA
• MDR Report Key: 9764755
• MDR Text Key: 184628081
• Report Number: 0008010177-2020-00012
• Device Sequence Number: 1
• Product Code: GXP
• UDI-Device Identifier: 07613327123371
• UDI-Public: 07613327123371
• Combination Product (y/n): N
• PMA/PMN Number: K143661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1