MAUDE Adverse Event Report: ENCORE MEDICAL L.P. CEMENT RESTRICTOR; PLUG, CEMENT SZ. 12.0

Model Number 415-00-120

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - surgeon went to pull out the cement plug inserter and half the cement plug was left in the patient and other half was on the inserter.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was due surgeon pulling out the cement plug inserter and half the cement plug was left in patient and other half was on the inserter.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The surgery was completed as intended and without incident.The evaluation was limited in scope as the item associated with this investigation was not returned to djo surgical - austin for examination.A review of the implant device history records shows that the reported component, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product that may have contributed to the reported event.The device was within its expiration date at the time of the surgery.The complaint history shows there are 15 complaints against this part number, 2 complaints against this lot number including the present complaint.This is the first incident of this failure against this part/lot number.The root cause of this complaint was half of the cement plug left in the patient.There were no findings during this evaluation that indicate that the reported device was defective.No further action is deemed necessary.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: CEMENT RESTRICTOR
• Type of Device: PLUG, CEMENT SZ. 12.0
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9496955
• MDR Text Key: 172214987
• Report Number: 1644408-2019-01202
• Device Sequence Number: 1
• Product Code: LZN
• UDI-Device Identifier: 00888912023467
• UDI-Public: (01)00888912023467
• Combination Product (y/n): N
• PMA/PMN Number: K032685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 415-00-120
• Device Catalogue Number: 415-00-120
• Device Lot Number: 7717171
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 89 YR