MAUDE Adverse Event Report: ARTHREX, INC. CHONDRALDRILL, HIP, DRILL BIT; BIT, DRILL

Model Number	CHONDRALDRILL¿, HIP, DRILL BIT
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the surgeon was using the beta launched chondral drill in the hip to perform a microfracture of the acetabulum.He had drilled approximately 6-7 times for his micro fracture already and then the tip of the drill broke off inside the joint.It was not buried in the bone but just floating down in the inferior portion of the joint.An additional portal was made to be able to retrieve the drill tip successfully.

• Brand Name: CHONDRALDRILL, HIP, DRILL BIT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10379213
• Report Number: 1220246-2020-02012
• Device Sequence Number: 14239338
• Product Code: HTW
• UDI-Device Identifier: 00888867235922
• UDI-Public: 00888867235922
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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 Expiration Date: 10/31/2024
• Device Model Number: CHONDRALDRILL¿, HIP, DRILL BIT
• Device Catalogue Number: AR-6585D
• Device Lot Number: 10453905
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/07/2020
• 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