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

Catalog Number	804-06-013
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the removal tool became stuck in the implant.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1644408-2019-01236
• Device Sequence Number: 2500762
• Product Code: HTO
• UDI-Device Identifier: 00888912148764
• UDI-Public: (01)00888912148764
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: E529270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 804-06-013
• Device Lot Number: 268900L02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 804-02-035, LOT 267068L01