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

Model Number	803-15-008
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - item broke during the case/tip was left in the patient.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
The reason for this instrument failure was reported as broken drill bit.The healthcare professional indicated this event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, with no delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The device was left in patient and not made available to manufacturer.Since, the device was not available and the evaluation was not done by registered medical assistant (rma) at djo surgical.The instrument was not returned for examination and the lot number was not reported.Without the lot number, the 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 shows no prior complaints filed against the instruments' item number that reports a similar failure.The root cause for this complaint cannot be determined with confidence as the instrument was not returned for investigational review.It is likely 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 systemic design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the instrument cannot be located at this time.The representative did not follow the proper rma return procedure and shipped the instrument with worn rmas.If the instrument is found at a later time, the complaint will be updated.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this instrument failure was reported as broken drill bit.The possible time in service of the main contributor of this complaint is 2 years and 2 months from manufactured date.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, with no delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The device was returned to manufacturer and evaluated by registered medical assistant (rma) at djo surgical.A review of the instrument's device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) associated with the production of this instrument.Complaint database review shows two prior complaints filed against the instruments' item number that reports a similar failure.Those are 2 - broke/cracked/damaged.However, the customer complaint history of the reported device showed no present trends or on-going issues that are needing review.The root cause of this complaint is likely 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 systemic design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the instrument was returned to djo and after further examination, the tip of the drill bit is broken off.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• 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
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 14493453
• Report Number: 1644408-2022-00702
• Device Sequence Number: 11915528
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2022

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: 323983L04
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 07/14/2022; 08/05/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/18/2022; 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Male