MAUDE Adverse Event Report: ENCORE MEDICAL L.P ALTIVATE REVERSE SHOULDER; ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 10X108MM

Model Number	530-10-108
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this complaint was presence of hair in the inner most layer of the packaging.The healthcare professional indicated there was a serious risk to the patient.There was a 5 minutes delay in surgery and another suitable device was available for use.The surgery was completed as intended.The device was returned to manufacturer and examined by registered medical assistant (rma) at djo surgical.Rma summary: the incident implant was returned to djo for examination.The implant is still sealed inside its innermost pouch, all other pouches and foam were removed from implant box.The location of the hair has been made obvious by the agent, who circled the area with a marker.The hair is about 0.5 inches in length, partially located in the inner pouch area and partially located within a pre-sealed edge.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
Primary surgery - during inspection of implant before opening onto the sterile field a hair was discovered inside the packaging of the implant.The hair was in the inner most layer (implant layer) of the packaging.Surgeon was able to grab another implant of the shelf so there was no disruption in the surgery.
Additional Manufacturer Narrative
The reason for this complaint was presence of hair in the inner most layer of the packaging.The healthcare professional indicated there was a serious risk to the patient.There was a 5 minutes delay in surgery and another suitable device was available for use.The surgery was completed as intended.The device was returned to manufacturer and examined by registered medical assistant (rma) at djo surgical.A review of the incident implant's device history record (dhr) showed no non-conforming material report (ncmr) associated with the production of this lot that may have contributed to the reported event.The root cause of this complaint was the inclusion of a hair in an implant pouch.Based on the location of the hair, stuck within one of the pre-sealed edges, it can be determined that the hair was introduced to the pouch at the pouch manufacturer's site.The photos, including some viewing the pouch under magnification, show that the hair is stuck in the pre-sealed side edge of the pouch, meaning it came like that from the pouch manufacturer.The error on djo's behalf was a clean room operator not noticing the pouch defect, and allowing the implant to be sealed inside the defective pouch.Djo's clean room supervisor has photographed the defect to show to their operators, to emphasize noticing this failure during the sealing process.Additionally, djo's quality assurance engineer for supplier quality has been made aware of this issue, and they will communicate this issue to the pouch manufacturer.There are no indications of a product or process issue affecting implant safety or effectiveness.Rma examination: the incident implant was returned to djo for examination.The implant is still sealed inside its innermost pouch, all other pouches and foam were removed from implant box.The location of the hair has been made obvious by the agent, who circled the area with a marker.The hair is about 0.5 inches in length, partially located in the inner pouch area and partially located within a pre-sealed edge.Photos are attached.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was presence of hair in the inner most layer of the packaging.The healthcare professional indicated there was a serious risk to the patient.There was a 5 minutes delay in surgery and another suitable device was available for use.The surgery was completed as intended.The device was returned to manufacturer and examined by registered medical assistant (rma) at djo surgical.A review of the incident implant's device history record (dhr) showed no non-conforming material report (ncmr) associated with the production of this lot that may have contributed to the reported event.Customer complaint history was reviewed for this failure.Eight prior complaints document instances in which a hair was mistakenly included within an implant's packaging.This number is not indicative of an upward trend, or a cause for quality alert.The root cause of this complaint was the inclusion of a hair in an implant pouch.Based on the location of the hair, stuck within one of the pre-sealed edges, it can be determined that the hair was introduced to the pouch at the pouch manufacturer's site.The photos, including some viewing the pouch under magnification, show that the hair is stuck in the pre-sealed side edge of the pouch, meaning it came like that from the pouch manufacturer.The error on djo's behalf was a clean room operator not noticing the pouch defect, and allowing the implant to be sealed inside the defective pouch.Djo's clean room supervisor has photographed the defect to show to their operators, to emphasize noticing this failure during the sealing process.Additionally, djo's quality assurance engineer for supplier quality has been made aware of this issue, and they will communicate this issue to the pouch manufacturer.There are no indications of a product or process issue affecting implant safety or effectiveness.Rma examination: the incident implant was returned to djo for examination.The implant is still sealed inside its innermost pouch, all other pouches and foam were removed from implant box.The location of the hair has been made obvious by the agent, who circled the area with a marker.The hair is about 0.5 inches in length, partially located in the inner pouch area and partially located within a presealed edge.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: ALTIVATE REVERSE SHOULDER
• Common Device Name: ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 10X108MM
• 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: 11812407
• Report Number: 1644408-2021-00411
• Device Sequence Number: 14394560
• Product Code: PHX
• UDI-Device Identifier: 00888912168366
• UDI-Public: (01)00888912168366
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2026
• Device Model Number: 530-10-108
• Device Catalogue Number: 530-10-108
• Device Lot Number: 409T1576
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/24/2021; 06/24/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 07/08/2021; 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other
• Patient Sex: Male