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

Catalog Number	804-03-008
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Problem - broke during surgery.
Additional Manufacturer Narrative
The reason for this complaint was to report the bone tap breaking during surgery.This event occurred during surgery near the patient.There was another suitable device available.This was a significant adverse event and the incident did cause a 15 minute delay in surgery, however; the surgery was completed as intended and the instrument was inspected prior to surgery and was found to be acceptable.The broken reamer was reported left in patient, therefore the reported problem could not be confirmed.The rma assigned to this complaint was issued in error since there will be no return of the item.The lot number was not reported; therefore, this instrument could not be linked to a specific device history record (dhr) or the actual date of manufacture could not be determined with confidence.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.Summary of complaints: 5 functional, 16 dull/worn, 1 locking mechanism damaged, 6 seized/galled, 4 threads damaged/galled, 25 bent, 38 broke/cracked/damaged, 5 end of life, 19 blank.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.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.Event is associated with instrument usage, not a design or manufacturing issue.

• Brand Name: RSP INSTRUMENT
• 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: 8725113
• Report Number: 1644408-2019-00554
• Device Sequence Number: 2221106
• Product Code: HTO
• UDI-Device Identifier: 00888912147842
• UDI-Public: (01)00888912147842
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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): 09/13/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1