MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; RSP TORQUE DRIVER

Catalog Number 804-03-038

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Instrument failure - the screw for the reverse glenoid broke.Surgeon implanted the glenoid head.He then inserted and tightened the screw into place using the torque limiting handle.The threads of the screw broke off inside then glenoid baseplate.Surgeon was not able to remove the glenoid head using the t handle removal tool or a bone hook.The decision was made to leave the threads of the screw in place and close the case.

Manufacturer Narrative

The reason for this instrument failure was reported as the broken screw in the glenoid baseplate.The healthcare professional indicated this event occurred post operative, near the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, with no delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.The device was not returned to manufacturer and evaluated by registered medical assistant (rma) djo surgical.A review of the device history record (dhr) could not be performed.Extensive review of records could not find a device history record (dhr) for the instruments lot.Complaint database review shows no prior complaints filed against the instruments item number that reports a similar failure.However, the customer complaint history of the reported device showed no present trends or on-going issues that are needing review.The root cause for this complaint cannot be determined with confidence as the instrument was not returned for investigational review.It 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 not returned to djo, and no further evaluation can be made for this event.This customer complaint will be closed.If the device is returned later, the complaint will be updated.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: RSP
• Type of Device: RSP TORQUE DRIVER
• 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: 14142749
• MDR Text Key: 295337672
• Report Number: 1644408-2022-00502
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912150842
• UDI-Public: (01)00888912150842
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 804-03-038
• Device Lot Number: 120181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 55 YR
• Patient Sex: Female