MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP ORTHOPEDIATRICS 2.5MM CALIBRATED DRILL BIT; BIT, DRILL

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to orthopediatrics for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

Reference: (b)(4).The follow is being submitted to relay additional information.Updated: b1: serious injury; b4: 21 feb 2020; g7: follow up report; h4 updated 06 jul 2018; h6: patient code 2687; h6: device code 1260; h6: method 4114, 4109 and 3331; h6: results 3252; h6: conclusion 4315.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 has been reported that during the placement of a locking cannulated blade plate, a drill bit fractured.The fractured portion 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 2.5MM CALIBRATED DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• MDR Report Key: 9720753
• MDR Text Key: 190696156
• Report Number: 3006460162-2019-00093
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00841132122884
• UDI-Public: (01)00841132122884(10)91801381-L
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• 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: 91801381-L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR