MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP HUMERAL SOCKET INSERT, 36MM +4MM, STANDARD HXE-PLUS

Model Number 509-00-436

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

The reason for this complaint was reported as incorrect lasering during production.The possible time in service for the main contributor of the complaint is 2 months from the manufacturer date.The healthcare professional indicated that this event occurred during inspection, near the patient.No risk or adverse event was reported by the surgeon.The agent was present during surgery and was able to source a suitable replacement device.The surgery was completed as intended, with no delay.The item was inspected prior to use and was deemed acceptable for use based on its appearance.The device was returned to manufacturer and made available to djo surgical for examination.A review of the item device history record (dhr) revealed the item, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the production of the item that are related to the reported issue.Complaint database review shows no prior complaints filed against the item number that reports a similar failure.No prior complaints report past instances of these items being affected by this failure.Review also shows no prior complaints against the item lot number.The root cause of this complaint is likely attributable to incorrect lasering during production.This is not an event associated with a product failure, malfunction or issue.There are no indications that this item has a systemic design or material deficiency.Therefore, no containment of inventory is required.Event is not associated with a design or manufacturing issue.Rma examination: the reported item was returned to djo and after further examination and size verification, shows that the rsp humeral socket insert has the correct dimensions of a 36mm insert however was lasered with the incorrect size of 32mm, confirming the complaint.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Primary surgery - the item was stamped with the incorrect size on it.

Manufacturer Narrative

Manufacturer narrative: the reason for this complaint was reported as incorrect lasering during production.The possible time in service for the main contributor of the complaint is 2 months from the manufacturer date.The healthcare professional indicated that this event occurred during inspection, near the patient.No risk or adverse event was reported.The agent was present during surgery and was able to source a suitable replacement device.The surgery was completed as intended, with no delay.The item was inspected prior to use and was deemed acceptable for use based on its appearance.The device was returned to manufacturer and evaluated by registered medical assistant (rma) djo surgical.A review of the items device history record (dhr) revealed the item, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of the item that are related to the reported issue.Reference (b)(4) for the detailed investigation.Per (b)(4) an investigation was conducted to assess that other lots were not affected by this failure, however, identified lot was withdrawn from the field.Complaint database review shows no prior complaints filed against the item number that reports a similar failure.No prior complaints report past instances of these items being affected by this failure.Review also shows no prior complaints against the item lot number.The root cause of this complaint is likely attributable to incorrect lasering during production.This is not an event associated with a product failure, malfunction or issue.Per (b)(4) an investigation was conducted to assess that other lots were not affected by this failure, however, identified lot was withdrawn from the field.Rma examination: the reported item was returned to djo and after further examination and size verification, shows that the rsp humeral socket insert has the correct dimensions of a 36mm insert however was lasered with the incorrect size of 32mm, confirming the complaint.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: RSP
• Type of Device: RSP HUMERAL SOCKET INSERT, 36MM +4MM, STANDARD HXE-PLUS
• 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: 12759016
• MDR Text Key: 280445096
• Report Number: 1644408-2021-01180
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912144582
• UDI-Public: (01)00888912144582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100741
• 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,Followup
• Report Date: 12/20/2021

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
• Device Operator: Health Professional
• Device Model Number: 509-00-436
• Device Catalogue Number: 509-00-436
• Device Lot Number: 386P1167
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male