MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DRILL BIT; DRILL BIT, 3.2X35MM, BAYONET

Model Number	803-15-008
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reason for this compliant was to report snapped drill bits when the surgeon was drilling into the cup for screws.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 disposed of at hospital and not made available to djo surgical for examination.The drill bit was lost/discarded, therefore the reported problem could not be confirmed.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 ifu.The lot number was not reported; therefore, this instrument could not be linked to a specific device history record (dhr) and the actual date of manufacture cannot be determined with confidence.Complaint database review showed no previous complaints and there were no indications that this instrument has a design or material deficiency.The root cause of the complaint was the event attributable to damage incurred through misuse or rough handling which surgical instruments are subjected to.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.
Event or Problem Description
Instrument failure - during surgery both drill bits snapped when the surgeon was drilling into the cup for screws.

• Brand Name: DRILL BIT
• Common Device Name: DRILL BIT, 3.2X35MM, BAYONET
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9764226
• Report Number: 1644408-2020-00162
• Device Sequence Number: 3268138
• Product Code: HTW
• UDI-Device Identifier: 00190446289265
• UDI-Public: (01)00190446289265
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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: 803-15-008
• Device Catalogue Number: 803-15-008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR