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

Catalog Number	804-03-051
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 - the glenosphere trial threads were stripped and got stuck in the patient.The impactor tip snapped off inside the glenoid trial.No pieces of the broken instruments remained in the patient.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was to report an instrument failure.The glenosphere trial threads were stripped and got stuck in the patient.The impactor tip snapped off inside the glenoid trial.No pieces of the broken instruments remained in the patient.This event occurred during surgery.The agent did not indicate whether the event occurred near or away from the patient.The agent did not indicate whether there was risk, adverse event, or negative outcome reported by the surgeon.The agent did not indicate whether the surgery was completed as intended, or if there was a delay.The agent did not indicate whether the instruments were inspected prior to use.The agent did not indicate whether they were present in the surgery, or if they were able to source replacement devices after the incident trial head and impactor malfunctioned.As of 05 may 2021, the retrun material authorization (rma) has not been returned to djo for examination.No further evaluation can be made for this event.This customer complaint will be closed.If the device is returned later, the complaint will be updated.Justification for no investigation: the instruments were not returned for examination and the lot numbers were not reported.Without the lot numbers, the instruments could not be linked to specific device history records and the actual dates of manufacture cannot be determine with confidence.An investigation cannot be conducted.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: IMPACTOR
• Common Device Name: GLENOID HEAD INSERTER/IMPACTOR
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 11101817
• Report Number: 1644408-2020-01210
• Device Sequence Number: 837634
• Product Code: HWA
• UDI-Device Identifier: 00888912148184
• UDI-Public: (01)00888912148184
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 804-03-051
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 804-03-043 LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR