MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP, BASEPLATE RIM PLANER 40MM* DO NOT BUY

Catalog Number	804-03-035
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reason for this instrument failure was reported as remains of thread in the discarded glenosphere.The possible time in service for baseplate is unknown from manufactured date.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk, adverse event, or negative outcome was reported by the surgeon.There was a 20 to 25 minute delay in surgery but the surgery was completed as intended.The instrument was inspected prior to use and was deemed acceptable for use based on their appearance.The device was returned to manufacturer and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical for review.The instrument was returned for examination and the lot number was not reported.Without the lot number, the instrument could not be linked to a specific device history record (dhr) and the actual date of manufacture cannot be determine with confidence.No further evaluation can be made for this event.Customer complaint history of the reported item showed no present trends or on-going issues that are needing a review.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Instrument failure - representative didn't have the correct distractor to remove the 44 mm glenoid head so this instrument broke during the revision surgery.The threads remain in the discarded glenosphere, but the rest of the instrument will be returned.No pieces of the broken instrument were left in the patient.

• Brand Name: RSP
• Common Device Name: RSP, BASEPLATE RIM PLANER 40MM* DO NOT BUY
• 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: 12733960
• Report Number: 1644408-2021-01170
• Device Sequence Number: 19857018
• Product Code: PHX
• UDI-Device Identifier: 00888912440998
• UDI-Public: (01)00888912440998
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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 Catalogue Number: 804-03-035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male