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

Catalog Number 804-06-013

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Instrument failure - blunt instrumentation preventing glenoid bone preparation to receive the reverse shoulder prosthesis baseplate.

Manufacturer Narrative

Manufacturer narrative: the reason for this complaint was reported as reamer became blunt and preventing glenoid bone preparation to receive baseplate.The possible time in service of the main contributor component is 3 years and 9 months from manufacturer date.The healthcare professional indicated that 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 agent was present during surgery however was unable to source a suitable replacement device.The devices were disposed of at hospital and not made available to djo surgical for examination.A review of the instrument's device history records (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 and 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 3-5 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 complaint will 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, SMALL
• 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: 13522883
• MDR Text Key: 288276482
• Report Number: 1644408-2022-00202
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 00888912148764
• UDI-Public: (01)00888912148764
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 804-06-013
• Device Lot Number: 268900L02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• 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: 804-06-012 LOT 236247L01; 804-06-013 LOT 268900L02; 804-06-014 LOT 268900L03; 804-06-014 LOT 268900L03
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG