MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HIP SURGICAL INSTRUMENT; DRILL BIT, 3-2 X 70, 60 EFFECTIVE

Model Number	803-05-230
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - upon drilling the screw hole for the cup, the tip of the drill broke.
Additional Manufacturer Narrative
The reason for this instrument failure complaint was due to the tip of the drill breaking upon drilling the screw hole for the cup.The drill bit was not returned therefore the reported event could not be confirmed, part of the drill bit was left in the patient.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 lot number or revision level were 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.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.The summary of complaints is as follows: 1- functional, 7- dull/worn, 2- bent, 12- broke/cracked/damaged, 5- blank.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.

• Brand Name: HIP SURGICAL INSTRUMENT
• Common Device Name: DRILL BIT, 3-2 X 70, 60 EFFECTIVE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7138139
• Report Number: 1644408-2017-01187
• Device Sequence Number: 1145023
• Product Code: HTW
• UDI-Device Identifier: 00888912104463
• UDI-Public: (01)00888912104463
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2018

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 Model Number: 803-05-230
• Device Catalogue Number: 803-05-230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 68