MAUDE Adverse Event Report: ENCORE MEDICAL L.P. GLENOID HEAD INSERTER/IMPACTOR

Model Number 804-03-051

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/28/2023

Event Type  Injury  

Event Description

Revision surgery - 20 minute delay in surgery.

Manufacturer Narrative

The agent reported (glenoid inserter screw thread tip broke off into glenosphere.) this event occurred during surgery, near the patient.The surgery was not completed as intended, and there was a twenty-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The instrument was used until breaking.The agent was present during surgery and was able to source a suitable replacement device.The instrument was returned to djo and after further examination, the screw threaded tip broke.Device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of this instrument.Complaint database review showed 7 previous complaints but there were no indications that this instrument has a design or material deficiency.The root cause of this complaint is likely attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction, or issue.There are no indications that this instrument has a systemic design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.

• Brand Name: GLENOID HEAD INSERTER/IMPACTOR
• Type of Device: IMPACTOR
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 16603655
• MDR Text Key: 311923451
• Report Number: 1644408-2023-00324
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 00888912148184
• UDI-Public: 00888912148184
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 804-03-051
• Device Catalogue Number: 804-03-051
• Device Lot Number: 274186L02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2018
• 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): Other
• Patient Age: 81 YR
• Patient Sex: Male