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

Catalog Number	804-03-008
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - tap broke off due to sclerotic bone while reaming.
Additional 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
• Common Device Name: 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
• Report Number: 1644408-2019-00553
• Device Sequence Number: 2637033
• Product Code: HTO
• UDI-Device Identifier: 00888912147842
• UDI-Public: (01)00888912147842
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: 804-03-008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR