MAUDE Adverse Event Report: ENCORE MEDICAL L. P. SHOULDER INSTRUMENT; DRILL BIT, 1/8"

Catalog Number	801-01-020
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
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 - due to item broke while using gen 1 glenoid drill guide.Drill broke at base of cutting flutes ~22mm from drill top.No pieces left in patient.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was a primary surgery reported as drill bit broke.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk,adverse event, or negative outcome were reported by the surgeon.The surgery was completed as intended, with a 90-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device when the incident drill bit broke.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 and the actual date of manufacture cannot be determine with confidence.An investigation cannot be conducted.Without a lot number reported, 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 rma examination: the reported instrument was not returned to djo for examination, the complaint form indicates it was lost or discarded.However, the agent did provide two photos of the instrument.Photos confirm the complaint: the drill has broken into two pieces, with the break occurring at the base of the cutting flutes.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: SHOULDER INSTRUMENT
• Common Device Name: DRILL BIT, 1/8"
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 11691043
• Report Number: 1644408-2021-00328
• Device Sequence Number: 14575866
• Product Code: HTW
• UDI-Device Identifier: 00888912042710
• UDI-Public: (01)00888912042710
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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 Catalogue Number: 801-01-020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR