MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 4.5 MM PILOT DRILL; SURGICAL DRILL

Model Number 01-1500-9016

Device Problem Fracture (1260)

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

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

Customer has indicated that the product is in process of being returned to orthopediatrics for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Reference#: (b)(4).

Event Description

It was reported that the tip of the 4.5 mm pilot drill broke intraoperatively.

• Brand Name: 4.5 MM PILOT DRILL
• Type of Device: SURGICAL DRILL
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer Contact: kriss anderson ; 2850 frontier drive; warsaw, in ; 2686379
• MDR Report Key: 10250838
• MDR Text Key: 219197841
• Report Number: 3006460162-2020-00075
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K172583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-1500-9016
• Device Lot Number: 4812-C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14 YR