MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; ALTIVATE ANATOMIC AG, GLENOID REAMER AP, SZ 50

Catalog Number	804-09-036
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Instrument failure - ap reamer made slight interference with the half wedge reaming guide.Surgeon was not comfortable moving forward.Preferred a shoulder reverse arthroplasty instead.Surgeon was unsure if he pushed to hard on the reamer.Slight damage on instruments, 20 minute delay in surgery.
Additional Manufacturer Narrative
See d3, d4 expiration date, g1, h6, h10 and h11.The agent reported "ap reamer made slight interference with the half wedge reaming guide.Surgeon was not comfortable moving forward.Preferred a shoulder reverse arthroplasty instead.Surgeon was unsure if he pushed to hard on the reamer.Slight damage on instruments." this event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.There was a 20 minute delay in surgery, but the surgery was completed as intended.The instruments were inspected prior to use and were found to be acceptable.The agent was present when this event occurred and was able to provide another suitable device.Rma examination: the reported device was returned to surgical for evaluation.There is slight wear on the device (see images).Unable to recreate the reported failure under power and manually.There is no clear interference occurring.A review of the instrument's device history records (dhr) revealed, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of the instrument that is related to the reported issue.Complaint database review showed no previous complaints that allege this same issue.There are no indications that the instrument has a design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.It is difficult to determine the root cause as the failure could not be recreated.It is possible that there was tissue or bone that was causing some interference.This is not an event associated with a product failure, malfunction, or issue.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE ANATOMIC AG, GLENOID REAMER AP, SZ 50
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENOVRE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 20013045
• Report Number: 1644408-2024-01270
• Device Sequence Number: 4362990
• Product Code: HTO
• UDI-Device Identifier: 00190446729181
• UDI-Public: 00190446729181
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: E529270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/04/2024

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: 804-09-036
• Device Lot Number: 10368020L03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 804-09-027 LOT: 10395803L03
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male