MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ENCORE SHOULDER 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	04/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - due to the screw on inserter shearing off upon impaction.Remnant of screw was left in humeral stem with no adverse effects.
Additional Manufacturer Narrative
The instrument was returned on 23 apr 2018.When the reported event occurred the instruments may have been in service for 1.7 years.This event occurred during surgery near the patient.There was another suitable device available, the incident did cause a 30 minute 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.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.A review of the complain history indicates (b)(4) complaints have been reported against this part number.(b)(4) for a missing component, (b)(4) for bent, and (b)(4) for broke/cracked/damaged.Examination of the returned inserter confirmed that the threaded tip, of the locking knob, is partially broken off (threaded tip left in stem).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.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.

• Brand Name: ENCORE SHOULDER 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: 7451188
• Report Number: 1644408-2018-00363
• Device Sequence Number: 1372897
• Product Code: FZX
• UDI-Device Identifier: 00888912171564
• UDI-Public: (01)00888912171564
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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: 123312L02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR