MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; ALTIVATE REVERSE GLENOID CANNULATED TAP, 6.5MM

Catalog Number	804-06-318
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
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
Complaint - surgeon used the cannulated 6.5 tap on power over the 2.4mm guidewire.As the tap was advanced into the bone, we heard a loud crack.The entire tap broke off in the patient.The patient's bone was the hardest bone the surgeon has experienced in practice.The surgeon had to use a broken screw removal set to remove the tap.He was planning on using the 6.5 wedged baseplate, but the hole became too big due to the extraction.He had to use an 8.0 baseplate, tap, and central screw.The final outcome was acceptable.There was a 20-30 minute delay in surgery.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to report number 1644408-2025-01060; unk-surg, s803 - broke/cracked/damaged, instrument failure.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE GLENOID CANNULATED TAP, 6.5MM
• 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: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 22846553
• Report Number: 1644408-2025-01195
• Device Sequence Number: 11852721
• Product Code: HWX
• UDI-Device Identifier: 00190446839200
• UDI-Public: 00190446839200
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: B089255
• 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): 12/10/2025

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 Catalogue Number: 804-06-318
• Device Lot Number: 088567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Male