MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 2.5 CALIBRATED DRILL BIT BIT, DRILL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Malfunction  

Manufacturer Narrative

(b)(4). Complaint sample was not returned for evaluation. Reported event was not confirmed. The dhr was reviewed and there were no process deviations that would have contributed to the failure. Risk management file review was deemed appropriate. Review of the complaint history determined that no further action is required as there were no trends identified. Root cause was unable to be determined.

Event Description

It was reported that during a fracture correction, the drill bit fractured inside the cancellous bone. The fractured portion of the drill bit remained in the patient's bone. A new drill bit was used to drill a new hole for the screw to be implanted. No adverse events have been reported as a result of the malfunction.

• Brand Name: 2.5 CALIBRATED DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsa, in ; 2670872
• MDR Report Key: 9742959
• MDR Text Key: 190698274
• Report Number: 3006460162-2019-00031
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (Y/N): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: DISTRIBUTOR,FOREIGN,HEALTH PR

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/06/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/23/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: N/A
• Device Catalogue Number: 01-1050-0032
• Device LOT Number: 00SKA-L
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial