MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP BASEPLATE, 30MM, W/P2 COATING

Model Number 508-32-204

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Primary surgery - surgeon was revising an exactech shoulder.When he attempted to implant the glenoid baseplate - the screw snapped.The patient has extremely hard bone.The screw remained buried in the bone as it was not removable.Surgeon had to use the exactech baseplate because screw placement was different (could not go back in same place as ours).Did not put in a djo product.

Manufacturer Narrative

Manufacturer narrative: the reason for this surgery was reported as rsp baseplate breaking during implantation.The event occurred during surgery, near the patient.The agent was present and inspected the implant prior to surgery, deeming its appearance acceptable before use.The complaint form indicates that the agent was able to find a suitable replacement device after the reported device broke during surgery, but ultimately a djo product was not implanted.The surgery was completed as intended, but with a 10-minute delay.The healthcare professional indicated a significant adverse event occurred, but also indicated that there was no negative outcome due to the event.A review of the device history record (dhr) shows that the baseplate met design and manufacturing requirements when released for use.There were no non-conforming material reports (ncmr) associated with the production of this lot that may have contributed to the reported event.No complaints have been filed against any other parts from the incident baseplate's production lot.The root cause of this complaint was an rsp baseplate breaking during implantation.Surgeons must use caution by considering the amount of force used while installing implants.The patient's "extremely hard bone" may have contributed to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.The baseplate's dhr evidences conformance to manufacturing standards for all parts in the production lot.This is an issue of user error, not of material deficiency.There are no indications of a product or process issue affecting implant safety or effectiveness.Rma examination: the incident baseplate was returned to djo.Examination confirms the complaint: the baseplate's center screw has broken, leaving behind ~.25 inches of the screw post.The screw fragment was not returned, it was left inside the patient.

• Brand Name: RSP
• Type of Device: RSP BASEPLATE, 30MM, W/P2 COATING
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 10143260
• MDR Text Key: 194829746
• Report Number: 1644408-2020-00438
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144391
• UDI-Public: (01)00888912144391
• Combination Product (y/n): N
• PMA/PMN Number: K112069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 508-32-204
• Device Catalogue Number: 508-32-204
• Device Lot Number: 769P1790
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR