MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DRILL BIT; DRILL BIT, 3.2X45MM, BAYONET

Model Number	803-15-009
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Instrument failure: drill bits broke, one was retrieved and the other was irretrievable.Bone was very hard.
Additional Manufacturer Narrative
The reason for this instrument failure was reported as drill bit broke.The health care professional indicated that this event occurred during surgery, near the patient.No risk or adverse event was reported.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 devices were broken into two pieces, one part was discarded and other left in patient and not made available to djo surgical for examination.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 two prior complaints filed against the instruments item number that reports a similar failure.Those are 2 - broke/cracked/damaged.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 was not returned to djo, and no further evaluation can be made for this event.This customer complaint will be closed.If the device is returned later, the complaint will be updated.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, 3.2X45MM, 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: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 12807476
• Report Number: 1644408-2021-01284
• Device Sequence Number: 4918123
• Product Code: HTW
• UDI-Device Identifier: 00190446289272
• UDI-Public: (01)00190446289272
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 01/05/2022

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: 803-15-009
• Device Catalogue Number: 803-15-009
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 803-15-008 LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male