MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC ORTHOPEDIATRICS 3.2MM CANNULATED DRILL, SHORT; BIT, SURGICAL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant products: item: 01-1400-0042, orthopediatrics 1.6mm x 200mm guide wire, threaded, lot: unknown.The returned drill bit was evaluated and the reported event was confirmed as fractured.A design history review was performed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Orthopediatrics will continue to monitor for trends.

Event Description

It has been reported that during the placement of a cannulated screw, a drill bit fractured.The fractured tip of the drill bit remains in the patient's bone.No adverse events have been reported as a result of the malfunction.

• Brand Name: ORTHOPEDIATRICS 3.2MM CANNULATED DRILL, SHORT
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer Contact: kriss anderson ; 2850 frontier drive; warsaw, in ; 2670872
• MDR Report Key: 9820538
• MDR Text Key: 190699792
• Report Number: 3006460162-2020-00043
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 0084113216875
• UDI-Public: (01)0084113216875(10)91902437-C
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• 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: 01-1400-0017
• Device Lot Number: 91902437-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1