MAUDE Adverse Event Report: ENCORE MEDICAL L.P REVERSE SHOULDER PROSTHESIS INSTRUMENT; DRILL GUIDE, TWO PIECE, RSP

Catalog Number	804-03-048
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2019
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 retaining screw for glenosphere broke off in baseplate due to cross threaded screw from 4 hold drill guide.
Additional Manufacturer Narrative
The agent reported "(retaining screw for glenosphere broke off in baseplate due to cross threaded screw from 4 hold drill guide.)." the event occurred during surgery near the patient.There was no negative outcome attributed to the event, there was no delay in surgery, and the surgery was completed as intended.The agent was present in surgery and inspected the device, believing it to appear acceptable before use.Another suitable device was not available after the surgeon encountered difficulty using the drill guide.Date rma returned: 1/12/20.Rma examination: the drill guide has returned for examination.It shows signs of wear consistent with its years of use.At least one thread on the thumb screw exhibits some damage, as the thread crests are not all oriented in the same direction.A review of the device history record has been conducted.There were no nonconforming material reports associated with the production of the drill guide that may have contributed to the reported event.The drill guide met design and manufacturing requirements when released for use.One complaint has been filed against another part from this lot.One prior complaint, (b)(4), has been filed against a drill guide, alleging that its thumb screw was responsible for damaging a baseplate's threads in a way that it couldn't accept a retaining screw.The most likely root cause of this issue is cross-threading between screw interfaces during surgery.A drill guide has a thumb screw that is threaded into a baseplate during surgery to maintain alignment while peripheral screws are being attached to the baseplate.The screw hole in the baseplate that accepts the drill guide's thumb screw is the same screw hole that will later accept a retaining screw after the glenosphere is attached to the baseplate.It's possible that the drill guide's thumb screw, if malaligned during installation or damaged, can cause damage to the threads of the baseplate, leaving the baseplate susceptible to later rejecting a retaining screw or causing a retaining screw to break if installed with enough force.Destructive testing was performed with the returned drill guide, in an attempt to replicate the surgeon's complaint that the drill guide's thumb screw caused damage to the baseplate's threads.The testing was successful at achieving this end goal, but it's still not clear whether the damage to the baseplate's threading was the result of the drill guide's thumb screw or if it was the result of rough handling during the installation of the retaining screw with a hex driver.Either method seems to be capable of damaging a baseplate's threads.While testing didn't prove that any/all cross-threading issues with the rsp system are the result of the thumb screws of drill guides, it did prove that drill guides' thumb screws can be a source of damage to the center screw hole of an rsp baseplate.

• Brand Name: REVERSE SHOULDER PROSTHESIS INSTRUMENT
• Common Device Name: DRILL GUIDE, TWO PIECE, RSP
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 9623392
• Report Number: 1644408-2020-00058
• Device Sequence Number: 2216788
• Product Code: FZX
• UDI-Device Identifier: 00888912148177
• UDI-Public: (01)00888912148177
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: 804-03-048
• Device Lot Number: 268819L01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 508-00-001, LOT UNKNOWN; 508-36-101 LOT: 869C2796
• Patient Sex: Male