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

Catalog Number	803-15-008
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The agent reported that (drill bit broke, bone was sclerotic.About one third stayed in the patient, the other 2/3 was discarded age-unk/gender-male).Rma examination: the instrument was not returned to djo for further examination, per product feedback form, two-thirds of the drill bit was discarded while the rest remains in patient.No further evaluation can be made for this event.This customer complaint will be closed.The revision level or lot number 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 twelve previous complaints but there were no indications that this instrument has a design or material deficiency.The root cause of this complaint is difficult to determine since the device was not returned for evaluation.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.
Event or Problem Description
Instrument failure - instrument broke, pieceleft in patient.

• Brand Name: DRILL BIT, 3.2X35MM, BAYONET
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19068592
• Report Number: 1644408-2024-00442
• Device Sequence Number: 6891389
• Product Code: HTW
• UDI-Device Identifier: 00190446289265
• UDI-Public: 00190446289265
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: B089255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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: 03/11/2024
• Initial Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male