MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; ALTIVATE ANATOMIC CS, HUMERAL PUNCH, SZ 1

Catalog Number	804-08-011
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/02/2024
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
Intrument failure - humerus fracture.
Additional Manufacturer Narrative
The agent reported "dr.(b)(6) wanted to cut the fins off size 1 cs edge trial.Proximal humerus fracture.He did cut the fins off of cs edge implant.Wanted a real look at it with trial." this event occurred during surgery, away from the patient.There was no delay in surgery and the surgery was completed as intended.The instruments was inspected prior to use and was found to be acceptable.The agent was present when this even occurred but was not able to provide another suitable device.The reported device was not returned to surgical for evaluation.The agency was contacted twice with no response.If at a later time the device is returned an amendment will be returned.The revision level or lot number was not reported; therefore, this instrument could not be linked to a specific device history record (dhr) or the actual date of manufacture could not be determined with confidence.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 user preference and instrument usage, not a design or manufacturing issue.The root cause of this complaint is due to the surgeon modifying the instrument and implant for visibility.It is unclear as to why the surgeon did not follow the surgical technique.There were no reported issues with the instrument/implant.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE ANATOMIC CS, HUMERAL PUNCH, SZ 1
• 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: 19480983
• Report Number: 1644408-2024-00838
• Device Sequence Number: 7319600
• Product Code: PKC
• UDI-Device Identifier: 00190446648420
• UDI-Public: 00190446648420
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K193226
• 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): 08/07/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 804-08-011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 520-08-018 LOT: 1923A1198
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female