MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HIP INSTRUMENT; DRILL BIT, 3-2 X 56, 45 EFFECTIVE

Model Number	803-05-229
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was to report that the drill bit broke while using it during surgery.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.There was no risk or adverse event reported and the instrument was inspected prior to surgery on 5 march 2020 and was found to be acceptable.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.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 previous complaints but there were no indications that this instrument has a design or material deficiency.Summary of complaints to date: 100 - functional 1; 102 - dull/worn 15: 302 - bent 5: 303 - broke/cracked/damaged 44: (blank) 3.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.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.Surgical instruments condition can be determined while being used for its intended purpose.The replacement of surgical instruments due to normal wear and tear does not indicate a product deficiency, failure or issue.No further action is deemed necessary at this time.
Event or Problem Description
Instrument failure - drill bit broke while using it during surgery.

• Brand Name: HIP INSTRUMENT
• Common Device Name: DRILL BIT, 3-2 X 56, 45 EFFECTIVE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx
• MDR Report Key: 9926104
• Report Number: 1644408-2020-00305
• Device Sequence Number: 2596674
• Product Code: HTW
• UDI-Device Identifier: 00888912104456
• UDI-Public: (01)00888912104456
• 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,Followup
• Report Date (Section B): 04/24/2020

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: 803-05-229
• Device Catalogue Number: 803-05-229
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 04/04/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR