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

Catalog Number	804-03-048
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Instrument failure - the surgeon was applying the baseplate drill guide to the implanted baseplate in order to prepare for the baseplate screws.The guide was placed on the baseplate and the center holding screw was tightened.Upon tightening the screw, everyone heard a snap.It was discovered that the tip of the screw had broken off inside the baseplate.There was enough depth to back the baseplate out with the screwdriver but the remaining tip was going to impede the glenosphere screw from seating.He removed the baseplate and a new one was implanted.
Additional Manufacturer Narrative
The reason for this complaint was to report the tip of the screw had broken off inside the baseplate.This event occurred during surgery near the patient.The instrument was not inspected prior to surgery, however, there was another suitable device available.The incident did not cause a delay in surgery, surgery was completed as intended and there was no risk or adverse event reported.The device was lost and not made available to djo surgical for examination.The drill guide was lost, therefore the reported problem could not be confirmed.The reported condition could possibly be a result of heavy use or misuse and care must be taken to avoid compromising their performance.The lot number was not reported; therefore, this instrument could not be linked to a specific device history record (dhr) and the actual date of manufacture cannot be determined with confidence.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.Summary of complaints: 11 functional, 6 dull/worn, 1 fit, 1 locking mechanism damaged, 2 seized/galled, 13 threads damaged/galled, 3 missing feature, 1 missing component, 6 bent, 80 broke/cracked/damaged, 5 hardware missing/lot and 1 end of life.The root cause of this complaint was tip of the screw had broken off inside the baseplate.This event is possibly attributable to repeated 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 design or material deficiency therefore no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Surgical instruments condition can be determined while being used for its intended purpose.The replacement of surgical instruments due to normal wear and tear does not indicate a product deficiency, failure or issue.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: DRILL GUIDE, TWO PIECE, RSP
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 10540776
• Report Number: 1644408-2020-00824
• Device Sequence Number: 14221469
• Product Code: FZX
• UDI-Device Identifier: 00888912148177
• UDI-Public: (01)00888912148177
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 12/10/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR