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

Model Number	804-03-051
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - instrument broke, parts left in patient.
Additional Manufacturer Narrative
The agent reported (the instrument listed above was used to insert the glenosphere onto the baseplate.After securing the glenosphere to the baseplate, the t handle was removed, and it was noticed that the threaded portion had broken off in the glenospherre.After some discussion it was determined that the threaded portion could not be removed and the glenosphere was determined to be stable).This event occurred during surgery, near the patient.The surgeon noted that possible glenosphere could disengage from baseplate.The surgery was completed as intended, with a five-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device, but the implant was deemed stable.Rma examination: the instrument was returned to djo and after further examination, the inserter threads broke off.A review of 804-03-051 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 8 previous complaints but there were no indications that this instrument has a design or material deficiency.S110 - threads damaged/galled,5.S303 - broke/cracked/damaged,3.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.

• Brand Name: GLENOID HEAD INSERTER/IMPACTOR
• Common Device Name: IMPACTOR
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 17046484
• Report Number: 1644408-2023-00676
• Device Sequence Number: 5177673
• Product Code: HWA
• UDI-Device Identifier: 00888912148184
• UDI-Public: 00888912148184
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/01/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 804-03-051
• Device Catalogue Number: 804-03-051
• Device Lot Number: 276005L01
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2018
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female