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

Model Number 508-32-204

Device Problems Malposition of Device (2616); Installation-Related Problem (2965); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2019

Event Type  Injury  

Event Description

Complaint - the surgeon had trouble assembling the standard 4-barrel rsp (reverse shoulder prosthesis) peripheral screw drill/screw guide to the baseplate during a case today.This issue added about 30 min to the case sequence of events noted below: after implantation of the baseplate, the surgeon attempted to thread the standard 4-barrel rsp (reverse shoulder prosthesis) peripheral screw drill/screw guide onto the baseplate, but it would not seat nor thread in properly.A second standard 4-barrel rsp (reverse shoulder prosthesis) peripheral screw drill/screw guide was brought in, and he attempted to assemble this one to the baseplate with no success.As a workaround, he used the inner sleeve of the guide (the drill guide portion) on its own by holding it in place manually in the 4 peripheral screw holes while drilling.Since the screw guide portion could not be assembled to the baseplate, he had to freehand the peripheral screw insertion.He used power to insert and hand tightened the last few threads for all 4 peripheral screws.The anterior and posterior screws seemed fine, but the superior and inferior screws did not seem to be seating flush.Per the surgical technique, he inserted and impacted the glenosphere and then threaded the glenoid head inserter back onto the glenosphere to test its taper engagement.The taper was not engaged.He made a second attempt to assemble the glenosphere and it failed the taper engagement test again.Then, the surgeon removed the superior and inferior screws in case these screws were preventing the taper engagement.At this point, he considered drilling the peripheral holes again.The previously used 4 barrel inner sleeve for drilling could not be used again because 2 screws are already implanted and prevented proper seating of the sleeve.As a last resort, a special single-barrel drill guide was brought in since it would not be impacted by the 2 existing screws.This instrument was new and had not been used before.It also was unable to be to properly assembled to the baseplate.The surgeon then freehanded the insertion of 2 new peripheral screws in the superior and inferior positions.This time the 2 screws seated better.Glenosphere implantation was successful and passed the final taper engagement test.The glenosphere retaining screw was inserted and assembled.2 clicks for the 22.5 in-lb (pound) torque-limiting driver were observed.

Manufacturer Narrative

Corrected data: see b1; d1; d2; d4; d11.Manufacturer narrative: the reason for this complaint was to report the instrument failure was due to the doctor having trouble assembling the standard 4-barrel rsp peripheral screw drill/screw guide to the baseplate during a case.The event occurred during surgery, near the patient.The agent was present.Another baseplate was not sourced, as the surgeon was able to finish the surgery with this device implanted in the patient.The drill guides were inspected and believed to be acceptable before use.The surgery was completed as intended, but with a 30-minute delay.No adverse event, patient risk, or negative outcome due to the incident were reported.The instruments involved in this complaint were not returned to djo for examination, and the concomitant baseplate was implanted.A review of the device history record cannot be conducted for the drill guides because their lot numbers were not provided, and they were not returned for examination.The baseplate's device history record shows that it met design and manufacturing requirements when released for use.There were no nonconforming material reports associated with the production of this lot that may have contributed to the reported event.No complaints have been filed against any other parts from the baseplate's lot.The following complaints report similar issues involving seating between baseplates and rsp drill guides: (b)(4) describes an issue where the drill guide froze onto the baseplate after installation.(b)(4) describes an issue where the drill guide was not engaging properly with the baseplate.(b)(4) and (b)(4) both describe issues where the drill guides would not seat flush with the baseplates.(b)(4) all describe issues where the drill guides' thumb screws would not lock into the baseplates.The implant and instruments involved in this complaint were not returned to djo for examination, so a definitive root cause cannot be determined.Possible root causes of this complaint include malalignment between baseplate and drill guides, cross-threading or damaged threads of the drill guides' thumb screws, the presence of any debris that could prevent proper engagement of the baseplate with the drill guides, or an unevenly reamed bone surface beneath the baseplate that prevented the drill guides from seating on it properly.

• Brand Name: REVERSE SHOULDER PROSTHESIS INSTRUMENT
• Type of Device: DRILL GUIDE, TWO PIECE, RSP
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758 6313
• MDR Report Key: 8655676
• MDR Text Key: 146621663
• Report Number: 1644408-2019-00523
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 00888912144391
• UDI-Public: (01)00888912144391
• Combination Product (y/n): N
• PMA/PMN Number: K112069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 508-32-204
• Device Catalogue Number: 804-03-048
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 508-32-204, LOT 769P1571.
• Patient Age: 77 YR