MAUDE Adverse Event Report: ENCORE MEDICAL L.P GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER; GUIDE, SURGICAL, INSTRUMENT

Model Number	804-03-008
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported (2 mm of 6.5 guide tap broke off into the patients glenoid during reaming.Surgeon decided it would cause more damage to remove and left it in the patient and proceeded with surgery intended.Incident report and appropriate measures taken.Male 84 yrs).This event occurred during surgery, near the patient.Significant adverse event was reported by the surgeon.The surgery was completed as intended, with a thirty-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.A piece of the instrument was left in the patient when the bone tap became dislodged in the implant.(2mm tip of the 6.5 tap).Rma examination: the instrument will not be returned to djo for evaluation, the hospital kept the remaining piece of the shaft.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 32 previous complaints.S303 - broke/cracked/damaged, 31.S801 - device cracked/broke, 1.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
Reported incident - 30 minute delay in surgery, part left in patient.

• Brand Name: GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• 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: 16969435
• Report Number: 1644408-2023-00628
• Device Sequence Number: 20228949
• Product Code: FZX
• UDI-Device Identifier: 00888912147842
• UDI-Public: 00888912147842
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/19/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 804-03-008
• Device Catalogue Number: 804-03-008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 84 YR
• Patient Sex: Male