MAUDE Adverse Event Report: ENCORE MEDICAL L. P. ALTIVATE REVERSE SHOULDER INSTRUMENT; ALTIVATE REVERSE, SMALL HUMERAL STEM IMPLANT INSERTER KNOB

Model Number	804-06-157
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 - due to when disengaging the stem inserter from the stem, upon removal, we noticed some threads were still in the implant stem.Case was completed without any harm to the patient or timing.Broken instrument.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was a instrument failure reported as some threads were still in the implant stem after removal.The possible time in service of the main contributor of the complaint is 3 years and 1 month from the manufacturer date.The healthcare professional indicated that this event occurred during surgery, near the patient and there was a significant adverse event to the patient.The surgery was completed as intended, with 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.The device was returned to manufacturer and made available at djo surgical for examination.A review of the instrument's device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the production of the instruments that are related to the reported issue.Complaint database review shows no prior complaints filed against the instruments' item number or lot number that reports a similar failure.No prior complaints report past instances of these instruments being affected by this failure.The root cause of this complaint was 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.There are no indications that this instrument has a systemic design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the reported instrument was returned to djo and after further examination, the threads of the altivate reverse, small humeral stem implant inserter knob are damaged, confirming the complaint.The reported condition of the above instruments could possibly be a result of repeated use, misuse, wear and care must be taken to avoid compromising their performance.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Additional Manufacturer Narrative
Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: ALTIVATE REVERSE SHOULDER INSTRUMENT
• Common Device Name: ALTIVATE REVERSE, SMALL HUMERAL STEM IMPLANT INSERTER KNOB
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd.; austin, TX 78758-5445
• MDR Report Key: 11782864
• Report Number: 1644408-2021-00383
• Device Sequence Number: 1021088
• Product Code: KWS
• UDI-Device Identifier: 00190446269106
• UDI-Public: (01)00190446269106
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K172351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 12/29/2021

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 Model Number: 804-06-157
• Device Catalogue Number: 804-06-157
• Device Lot Number: 266605L04
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 10/14/2021; 10/14/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 10/25/2021; 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2018
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 68 KG