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

Model Number	804-03-048
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
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
Instrument failure - the set screw in the instrument assembly broke off in the baseplate.Surgeon was able to remove the base plant and implanted a new baseplate.
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
Instrument failure - the set screw in the instrument assembly broke off in the baseplate.Surgeon was able to remove the base plant and implanted a new baseplate.
Additional Manufacturer Narrative
The reason for this instrument failure was reported as broken screw in baseplate.The possible time in service for baseplate is 14 years and 1 month from manufactured date.The healthcare professional indicated there was a significant adverse event to the patient.The surgery was completed as intended, with a five-ten-minute delay.The instrument was not inspected prior to use and was deemed acceptable for use based on its appearance.The devices were returned to manufacturer and evaluated by registered medical assistant (rma) at djo surgical.A review of the instrument's device history records (dhr) revealed the instruments, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the production of this instruments.Complaint database review shows twenty-eight prior complaints filed against the instruments item number that reports a similar failure.Those are 1 - threads damaged/galled and 27 - 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.It is also a possibility that the drill guide was cross threaded into the baseplate which leads to breakage during torqueing.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 instrument was returned to djo and after further examination, the thumb screw of the drill guide, two piece, rsp is broken at the threaded tip.The baseplate was not returned.The reported condition of the above instrument 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.

• Brand Name: DRILL GUIDE
• 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: 13590889
• Report Number: 1644408-2022-00252
• Device Sequence Number: 5913079
• Product Code: FZX
• UDI-Device Identifier: 00888912148177
• UDI-Public: (01)00888912148177
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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 Model Number: 804-03-048
• Device Catalogue Number: 804-03-048
• Device Lot Number: 37883L01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2007
• 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 769P2215
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male