MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER

Catalog Number	804-03-008
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - while the surgeon was reaming over the tap, the tap broke in the glenoid.
Additional Manufacturer Narrative
The instrument was returned on 24 oct 2017.When the reported event occurred the instrument may have been in service for over 6.5 years.This event occurred during surgery near the patient.There was not another suitable device available, the incident did cause a 1.5 hour delay in surgery and this was a significant adverse event, however; surgery was completed as intended and the instrument was inspected prior to surgery and was found to be acceptable.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of this part.Examination of the returned reamer shows the threads have broken off (all pieces returned), confirming the complaint.The reported condition could possibly be a result of heavy use/misuse/wear and care must be taken to avoid compromising their performance.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.Surgical instruments condition can be determined while being used for its intended purpose.The replacement of surgical instruments due to normal wear and tear does not indicate a product deficiency, failure or issue.No further action is deemed necessary at this time.There are no indications that this instrument has a design or material deficiency therefore no containment of inventory is required.

• Brand Name: RSP SHOULDER
• Common Device Name: GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 7005993
• Report Number: 1644408-2017-00946
• Device Sequence Number: 1117514
• Product Code: FZX
• UDI-Device Identifier: 00888912147842
• UDI-Public: (01)00888912147842
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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: 804-03-008
• Device Lot Number: 53552L03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 62 YR