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

Model Number	79-45910
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	12/13/2019
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 company representative that while the surgeon was squeezing out direct inject, the tip of the applicator broke, causing the contents to spill out.Back up direct inject was available and the procedure was completed successfully.
Event or Problem Description
It was reported by the company representative that while the surgeon was squeezing out direct inject, the tip of the applicator broke, causing the contents to spill out.Back up direct inject was available and the procedure was completed successfully.
Additional Manufacturer Narrative
The reported event could be confirmed based on the returned product.It can be observed that the plunger is pressed down the complete way, indicating that all cement was transferred into the mixer cannula.It can be noticed that the right part of the interface between the mixer cannula (not returned) and the delivery syringe is broken away.Based on the shape of the broken portion it does seem to be within reason to conclude that this was exposed to too high forces and resulting an overload situation.This contradicts to the additional information provided by the sales rep: no extensive pressure was applied on the delivery syringe.Based on the information available the root cause of the complaint is related to an overload on the syringe.Based on the investigation including a statistical analysis, the review of all relevant quality and manufacturing documents as well as based on the inspection of the returned product, there is no indication for a not correctly working product or any systematic design, material or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at that time.However, post market surveillance will continue to monitor complaints of this type.The complaint is added to the complaint trend.

• 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: 9565123
• Report Number: 0008010177-2020-00002
• Device Sequence Number: 19285059
• Product Code: GXP
• UDI-Device Identifier: 07613327123272
• UDI-Public: 07613327123272
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143661
• 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): 07/30/2020

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: 79-45910
• Device Catalogue Number: 79-45910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1