MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER

Catalog Number 804-03-008

Device Problem Break (1069)

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

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Instrument failure - surgeon was in the process of reaming the glenoid and the tap snapped off at the thread.Surgeon was able to redirect an alternate tap and complete procedure.The remaining tap was not retrievable and therefore left behind.The remainder of the tap will be returned to djo.

Manufacturer Narrative

Manufacturer narrative: the reason for this instrument failure was reported as tap snapped off at the thread.The possible time in service for reamer is 5.5 years.This event occurred during surgery near the patient.There was another suitable device available, the incident did not cause a delay in surgery, surgery was completed as intended, there was no risk or adverse event reported and the instrument was inspected prior to surgery and was found to be acceptable.The device was returned to manufacturer 22 jul 2020 and examined by registered medical assistant (rma).Examination confirmed the complaint, the returned bone tap is broken at the drill flutes ( piece not returned).The reported condition could possibly be a result of heavy use, misuse, wear and care must be taken to avoid compromising their performance, refer to the ifu.A review of the device history record (dhr) revealed, when released for use, the item met design and manufacturing requirements.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.There had been one previous complaint against the reported lot number.Summary of complaints: 5 functional, 16 dull/worn,1 locking mechanism damaged, 6 seized/galled, 4 threads damaged/galled, 25 bent, 41 broke/cracked/damaged, 1 device cracked/broke, 55 end of life an 20 blank.The root cause of this instrument failure was tap snapped off at the thread.This event is 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.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.

• Brand Name: RSP
• Type of Device: GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• MDR Report Key: 10312119
• MDR Text Key: 201358798
• Report Number: 1644408-2020-00581
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 00888912147842
• UDI-Public: (01)00888912147842
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 804-03-008
• Device Lot Number: 161001L01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 78