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

Catalog Number 804-06-013

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2019

Event Type  malfunction  

Event Description

Instrument failure - the removal tool became stuck in the implant.

Manufacturer Narrative

Corrected data: see e.1.Manufacturer narrative: the reason for this compliant was to report "the glenosphere removal tool we will not be getting back as it went to a lab for culture testing on an infected patient.The removal tool became stuck in the implant.The reamer we can send back.Possible time in service: 1.8 years.This event occurred post-operative near the patient.There was another suitable device available, the incident did not cause a delay in surgery, surgery was completed as intended, there was no risk or adverse event reported and the instruments were inspected prior to surgery and found acceptable.It has been in excess of 84 days since the issuance of the rpr and the instrument has not been returned for investigation review as outlined in sales policy #4304.Section d.5.(of the attached product feedback form) indicates lost/discarded, however, the aforementioned reamer has not been returned.Instruments are subjected to heavy use/misuse/wear and care must be taken to avoid compromising their performance.Refer to the instrument ifu.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.Summary of complaints for (b)(4): 1 functional, 3 dull/worn, 2 threads damaged/galled, 1 dimensional concern, 11 bent, 6 broke/cracked/damaged, 1 revision surgery, 1 end of life.Summary of complaints for (b)(4) : 1 functional.The root cause of this event is 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 design or material deficiency therefore no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.

Event Description

Instrument failure - the glenosphere removal tool, we will not be getting back as it went to a lab for culture testing on an infected patient.The removal tool became stuck in the implant.The reamer we can send back.

• Brand Name: RSP INSTRUMENT
• Type of Device: RSP GLENOID HALF-MOON REAMER, SMALL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445, TX 78758 5445
• MDR Report Key: 9418035
• MDR Text Key: 176046418
• Report Number: 1644408-2019-01236
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 00888912148764
• UDI-Public: (01)00888912148764
• Combination Product (y/n): N
• PMA/PMN Number: E529270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 804-06-013
• Device Lot Number: 268900L02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 804-02-035, LOT 267068L01