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

Catalog Number	804-03-048
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the center threaded piece of the drill guide, that threads into the baseplate, broke off in the baseplate during surgery.The surgeons had to remove the baseplate with pliers and put in a new baseplate.Nothing was left in the patient.
Additional Manufacturer Narrative
The instrument was returned on 12 sep 2018.When the reported event occurred the instrument may have been in service for 7.5 years.This event occurred during surgery near the patient.There was another suitable device available, the incident did cause a 15 minute delay in surgery, a significant adverse event was indicated, however, surgery was completed as intended and the instrument was inspected prior to surgery and was found to be acceptable.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of this part.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.There are 2 complaints against the reported lot number.The complaint history for the reported part number is as follows: functional -8, dull/worn -6, fit -1, locking mechanism damaged -1, seized/galled -2, threads damaged/galled -12, missing feature -3, missing component -1, bent -5, broke/cracked/damaged -70, hardware missing/lost -5, end of life -1.Examination of the returned drill guide confirmed the threaded tip of the thumb screw broke off (tip not returned).The reported condition could possibly be a result of heavy use/misuse and care must be taken to avoid compromising their performance.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.

• Brand Name: RSP INSTRUMENT
• 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: 7839693
• Report Number: 1644408-2018-00828
• Device Sequence Number: 1155740
• Product Code: FZX
• UDI-Device Identifier: 00888912148177
• UDI-Public: (01)00888912148177
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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
• Device Lot Number: 39345L05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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: 66 YR