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

Model Number	415-00-120
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem 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.
Additional 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
• Common Device Name: PLUG, CEMENT SZ. 12.0
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9496955
• Report Number: 1644408-2019-01202
• Device Sequence Number: 1304899
• Product Code: LZN
• UDI-Device Identifier: 00888912023467
• UDI-Public: (01)00888912023467
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2020

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 89 YR