MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM

Model Number 508-32-104

Device Problem Break (1069)

Patient Problem Paralysis (1997)

Event Date 01/18/2022

Event Type  Injury  

Manufacturer Narrative

The reason for this revision surgery was reported as broken screw.The previous surgery and the surgery detailed in this event occurred 3 months and 3 weeks apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were returned for examination and the device evaluation anticipated but not yet begun at djo surgical.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to broken screw.There were no findings during this evaluation that indicate the reported devices were defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - patient has a paralyzed right arm, partial fused back and fused left wrist.He solely uses left arm to lift themselves.He had broken the 6.5mm screw on baseplate.The baseplate, glenoid head and all four locking screws pulled out of glenoid.The remaining screw of the baseplate was also extracted.

Manufacturer Narrative

The reason for this revision surgery was reported as broken screw.The previous surgery and the surgery detailed in this event occurred 3 months and 3 weeks apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were returned for examination and the device evaluation anticipated but not yet begun at djo surgical.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to broken screw.There were no findings during this evaluation that indicate the reported devices were defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - patient has a paralyzed right arm, partial fused back and fused left wrist.He solely uses left arm to lift themselves.He had broken the 6.5mm screw on baseplate.The baseplate, glenoid head and all four locking screws pulled out of glenoid.The remaining screw of the baseplate was also extracted.

• Brand Name: RSP
• Type of Device: BASEPLATE, GLENOID HA-COAT, RSP, 6.5MM X 30MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 13479967
• MDR Text Key: 285320758
• Report Number: 1644408-2022-00150
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024754
• UDI-Public: (01)00888912024754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 508-32-104
• Device Catalogue Number: 508-32-104
• Device Lot Number: 866C2908
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 506-03-114 LOT 831C1937; 506-03-118 LOT 832C1777; 506-03-118 LOT 832C1787; 506-03-118 LOT 832C1788; 508-00-032 LOT 855C2346; 508-32-101 LOT 862C3453
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 78 KG