MAUDE Adverse Event Report: ENCORE MEDICAL L.P. REAMER; RSP GLENOID HALF-MOON REAMER, STARTER

Catalog Number 804-06-012

Device Problem Dull, Blunt (2407)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

Instrument failure - blunt instrumentation when reaming glenoid bone.Had to resort to full moon reamer but was not happy, as access was difficult.

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Manufacturer Narrative

The reason for this instrument failure was reported as blunt instrumentation.The possible time in service of the main contributor of this complaint is 4 years and 7 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 devices were not returned to manufacturer and not 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 were no non-conforming material reports (ncmr) associated with the production of this instrument.Complaint database review shows three prior complaints filed against the instruments item number that reports a similar failure.Those are 2 - functional, 1 - dull/worn.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 the time of service of the instruments.According to the dhrs, the reamers may have been in the field for 4 years which can contribute to dulling of the cutting edges.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, and no further evaluation can be made for this event.This customer complain twill be closed.If the device is returned later, the complaint will be updated additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: REAMER
• Type of Device: RSP GLENOID HALF-MOON REAMER, STARTER
• 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: 13534211
• MDR Text Key: 288356376
• Report Number: 1644408-2022-00208
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 00888912148757
• UDI-Public: (01)00888912148757
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: E529270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 804-06-012
• Device Lot Number: 236237L01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 804-06-013 LOT 294172L02; 804-06-014 LOT 294172L03
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Female