MAUDE Adverse Event Report: ENCORE MEDICAL L.P. SHOULDER SURGICAL INSTRUMENT; ENCORE REVERSE SHOULDER HUMERAL TRIAL/IMPLANT INSERTER, STD

Model Number	804-06-056
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the surgeon was performing a reverse total shoulder procedure when the screw in the altivate impactor handle broke upon impaction.The case was without incident until the surgeon impacted the stem into the humerus.As he was hitting the impact plate of the handle, the retention screw loosened, thusly allowing additional forces to act upon the screw.The balance of the screw was left in the implant (530-12-108).The surgeon dictated the incident in his notes.
Additional Manufacturer Narrative
To date the implant inserter has not been returned for investigational review.When the reported event occurred the instrument may have been in service for over 2.3 years.This event occurred during surgery 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 instrument was inspected prior to surgery and was found to be acceptable.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of this part.Customer complaints review showed previous complaints but there were no indications that this instrument has a design or material deficiency.The summary of complaints is as follows: 2 - broke/cracked/damaged.The root cause for the initial problem cannot be determined with confidence as the instrument was not returned for investigational review.No containment of inventory required, material or design issues cannot be identified.

• Brand Name: SHOULDER SURGICAL INSTRUMENT
• Common Device Name: ENCORE REVERSE SHOULDER HUMERAL TRIAL/IMPLANT INSERTER, STD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7147577
• Report Number: 1644408-2017-01183
• Device Sequence Number: 19115826
• Product Code: FZX
• UDI-Device Identifier: 00888912171564
• UDI-Public: (01)00888912171564
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• 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): 01/26/2018

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 Model Number: 804-06-056
• Device Catalogue Number: 804-06-056
• Device Lot Number: 180052L02
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 60