MAUDE Adverse Event Report: ENCORE MEDICAL L. P. REVERSE SHOULDER PROSTHESIS INSTRUMENT; DRILL GUIDE, TWO PIECE, RSP

Catalog Number	804-03-048
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2021
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 screw in the drill guide broke off in the reverse shoulder prosthesis baseplate (508-32-204).The surgeon had to remove the implanted baseplate and replace it with a new one.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was reported as broken screw in drill guide.The possible time in service for baseplate is 3 years and 11 months from manufactured date.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk, adverse event, or negative outcome were reported by the surgeon.The surgery was completed as intended, with a ten-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery but was unable to source a suitable replacement device.The device was returned to manufacturer and evaluated by registered medical assistant (rma) djo surgical.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 twenty-six prior complaints filed against the instruments item number that reports a similar failure.Those are 26 - broke/cracked/damaged.The root cause of this complaint is 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 thumb screw is broken at the threaded tip (tip not returned).This is the only piece of the instrument that was returned.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was reported as broken screw in drill guide.The possible time in service for baseplate is 3 years and 11 months from manufactured date.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk, adverse event, or negative outcome were reported by the surgeon.The surgery was completed as intended,with a ten-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery but was unable to source a suitable replacement device.The device was returned to manufacturer and evaluated by registered medical assistant (rma) djo surgical.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 twenty-six prior complaints filed against the instruments item number that reports a similar failure.Those are 26 - broke/cracked/damaged.No prior complaints report past instances of these instruments being affected by this failure.The root cause of this complaint is 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 thumb screw is broken at the threaded tip (tip not returned).This is the only piece of the instrument that was returned.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: REVERSE SHOULDER PROSTHESIS INSTRUMENT
• Common Device Name: DRILL GUIDE, TWO PIECE, RSP
• 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: 11758004
• Report Number: 1644408-2021-00370
• Device Sequence Number: 4308970
• Product Code: FZX
• UDI-Device Identifier: 00888912148177
• UDI-Public: (01)00888912148177
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 02/16/2022

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: 804-03-048
• Device Lot Number: 238415L01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 12/21/2021; 02/04/2022
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 01/16/2022; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 508-32-204 LOT 769P1986
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male