MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP BASEPLATE DRILL LOCKING SCREW GUIDE

Catalog Number	S-200698
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the screw in the reverse shoulder prosthesis glenoid head would not engage the baseplate.Broken drill guide screw.Initially surgeon thought it was a defective baseplate.Later he realized that the screw in the two barrel guide was broken.Surgeon determined that the screw was broken off in the baseplate.
Additional Manufacturer Narrative
The reason for this instrument failure was reported as broken drill guide screw.The healthcare professional indicated this event occurred during surgery, near the patient.No risk or adverse event was reported.The surgery was completed as intended, with a twenty-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The device devices were returned to manufacturer and evaluated by registered medical assistant (rma) djo surgical.The instrument's lot number was not reported and cannot be found on the item.Without the lot number, the instrument could not be linked to a specific device history record (dhr) and the actual date of manufacture cannot be determine with confidence.Complaint database review shows two prior complaints filed against the instruments' item number that reports a similar failure.No prior complaints report past instances of these instruments being affected by this failure.Those are 1 - broke/cracked/damaged & 1 - threads damaged/galled.This event is likely 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 systemic design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the instrument was returned to djo and upon further examination found that the thumb screw threads are damaged and tip broken off inside of the rsp baseplate, 30mm, w/p2 coating, confirming the complaint.The reported condition could possibly be a result of heavy use or misuse.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: RSP
• Common Device Name: RSP BASEPLATE DRILL LOCKING SCREW GUIDE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12917783
• Report Number: 1644408-2021-01386
• Device Sequence Number: 11888744
• Product Code: FZX
• UDI-Device Identifier: 00888912150637
• UDI-Public: (01)00888912150637
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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: S-200698
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 506-03-114 LOT 831C1862; 506-03-114 LOT 831C1922; 508-32-204 LOT 769P2006
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 52 KG