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

Catalog Number 804-03-008

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/20/2019

Event Type  malfunction  

Event Description

Instrument failure - tap broke off due to sclerotic bone while reaming.

Manufacturer Narrative

The reason for this complaint was the bone tap breaking while reaming.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The primary surgery was completed as intended.The instrument was inspected prior to surgery and was found to be acceptable.The instrument was disposed of at the hospital and not made available to djo surgical for examination.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.Summary of complaints: 5 functional, 12 dull/worn, 1 locking mechanism damaged, 6 seized/galled, 4 threads damaged/galled, 25 bent, 37 broke/cracked/damaged, 5 end of life, 19 blank.The lot number was not reported; therefore, this instrument could not be linked to a specific device history record (dhr) or the actual date of manufacture could not be determined with confidence.The root cause of this event is attributable to damage due to sclerotic bone while reaming.The broken reamer was reported lost/discarded, therefore the reported problem could not be confirmed.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.The return material authorization assigned to this complaint was issued in error since there will be no return of the item.The reported condition could possibly be a result of heavy use or misuse and care must be taken to avoid compromising their performance.Refer to the instrument instruction for use (ifu).Event is associated with instrument usage, not a design or manufacturing issue.

• Brand Name: RSP INSTRUMENT
• Type of Device: GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8727900
• MDR Text Key: 149077317
• Report Number: 1644408-2019-00553
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 804-03-008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR