MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HUMERAL SHOULDER STEM; 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	10/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Instrument failure - due to stem inserter tip knob shearing off during the use of surgery.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was reported as the stem inserter tip knob sheared off.The possible time in service of the inserter is 2.9 to 3.2 years.The instrument was inspected prior to surgery and was found to be acceptable.The event occurred during surgery near the patient, there was another suitable device available, the incident did cause a 20 min.Delay in surgery, however, surgery was completed as intended and there was no risk or adverse event reported.Examination of the returned locking knob (the rest of the inserter was disposed of) shows the threaded tip broken off (tip not 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, refer to the ifu.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.There had been 6 previous complaints against the reported lot number.Summary of complaints: 2 missing component, 1 bent, 9 broke/cracked/damaged and 1 other.A review of the device history record (dhr) revealed, when released for use, met design and manufacturing requirements.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.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.

• Brand Name: HUMERAL SHOULDER STEM
• 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 TX 78758 5445
• MDR Report Key: 9582926
• Report Number: 1644408-2020-00019
• Device Sequence Number: 19268003
• Product Code: FZX
• UDI-Device Identifier: 00888912171564
• UDI-Public: (01)00888912171564
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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 Model Number: 804-06-056
• Device Catalogue Number: 804-06-056
• Device Lot Number: 183312L02
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR