MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ORTHOLOC® DRILL BIT 1/8; KNEE INSTRUMENT

Model Number	16109008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event will be updated when the investigation is complete.
Event or Problem Description
Allegedly , tip of 1/8 advance drill bit broke off in patient while drilling tibial screw holes.Approx 10mm remained in-situ.Instead of a screw being implanted into the fourth hole on the biofoam, the broken piece of the drill bit remains in place.3 screws only were implanted.(b)(6).
Additional Manufacturer Narrative
The alleged complaint is confirmed.This complaint was reported by a microport distributor.The device history records were reviewed for all products listed and the products met specification at the time they were manufactured.This failure mode is listed in the device package insert and risk documentation.The instrument cleaning and handling instructions (150802-2) indicate that the instruments are susceptible to damage over time and should be inspected prior to and after each use.In addition, the cleaning and handling instructions also state, "end of functional life is normally determined by wear and damage due to use." per the incident description, the product was not returned.No images were provided for evaluation.There were no trends identified.This issue will continue to be monitored through complaint tracking.
Event or Problem Description
Allegedly , tip of 1/8 advance drill bit broke off in patient while drilling tibial screw holes.Approx 10mm remained in-situ.Instead of a screw being implanted into the fourth hole on the biofoam, the broken piece of the drill bit remains in place.3 screws only were implanted.

• Brand Name: ORTHOLOC® DRILL BIT 1/8
• Common Device Name: KNEE INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9397504
• Report Number: 3010536692-2019-01155
• Device Sequence Number: 2739144
• Product Code: GFG
• UDI-Device Identifier: M684161090081
• UDI-Public: M684161090081
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 16109008
• Device Catalogue Number: 16109008
• Device Lot Number: 606411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR