MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER INSTRUMENT; ALTIVATE REVERSE, HUMERAL SOCKET SHELL TRIAL, STANDARD

Model Number	804-06-036
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the screw holding the broach and trial cup together broke off inside of broach during trialing of surgery.
Additional Manufacturer Narrative
Corrected data: manufacturer narrative: the instrument(s) were returned on 03 apr 2017.When the reported event occurred the instruments may have been in service for over: (lot # 224643l01) 4 months and (lot # 178881l01) 1.5 years.This event occurred during surgery near the patient.There was not another suitable device available, the incident did cause a 15 min.Delay in surgery, a significant adverse event was reported, however, surgery was completed as intended, 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 these parts.Review of complaint history indicates to date (3 aug 2017) 30 complaints have been reported against this part number.10 for a missing retaining clip and 20 for a broken screw.Of the 20 for a broken screw, 11 of them are for this lot number.Examination of the returned humeral socket shell trial shows the screw shaft broken off of at undercut below the head, broken piece remains in the returned humeral broach, confirming the complaint.Per health hazard evaluation (b)(4) the root cause for failure mode broken screw is design: hex drill point and depth not controlled leading to thin wall condition.

• Brand Name: RSP SHOULDER INSTRUMENT
• Common Device Name: ALTIVATE REVERSE, HUMERAL SOCKET SHELL TRIAL, STANDARD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6473261
• Report Number: 1644408-2017-00221
• Device Sequence Number: 19034950
• Product Code: FZX
• UDI-Device Identifier: 00888912171373
• UDI-Public: (01)00888912171373
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/01/2017

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 Model Number: 804-06-036
• Device Catalogue Number: 804-06-152
• Device Lot Number: 224643L01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 804-06-152,LOT 224643L01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR