MAUDE Adverse Event Report: ENCORE MEDICAL L.P DRILL GUIDE; SPECIAL, ALTIVATE REVERSE SNGL BRRL DRILL/SCRW GUIDE W/HNDL

Catalog Number	S-201262
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - while surgeon was screwing the special instrument "single barrel" reverse glenoid baseplate drill guide the tip of the set screw snapped off in the baseplate center hole.Surgeon decided to leave the broken screw tip in the baseplate.Surgeon inserted cocking screws in the baseplate and implanted the glenosphere without the retaining screw.
Additional Manufacturer Narrative
The reason for this complaint was reported as a tip of the drill guide was broken.The possible time in service for baseplate is 2 years and 4 months from manufactured date.The healthcare professional indicated this event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, with a three-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The device was not returned to manufacturer and evaluated by registered medical assistant (rma) at 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 this instrument.Complaint database review shows no prior complaints filed against the instrument item number that reports a similar failure.However, the customer complaint history of the reported device showed no present trends or on-going issues that are needing review.The root cause for this complaint cannot be determined with confidence as the instrument was not returned for investigational review.It 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 instrument was not returned to djo, as it was lost during the process of return.As stated in the attachments, the agency did not use the label provided to ship the instrument therefore it cannot be located at this time.No further evaluation can be made for this event.This customer complaint will be closed.If the device is returned later, the complaint will be updated.The rma process has been revised for better controls.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: SPECIAL, ALTIVATE REVERSE SNGL BRRL DRILL/SCRW GUIDE W/HNDL
• 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: 13667771
• Report Number: 1644408-2022-00271
• Device Sequence Number: 4776699
• Product Code: FZX
• UDI-Device Identifier: 00190446334187
• UDI-Public: (01)00190446334187
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2022

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: S-201262
• Device Lot Number: 305236L01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2019
• 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: 72 YR
• Patient Sex: Female