MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 5.0MM CANNULATED DRILL BIT; BIT, DRILL

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

Reference: (b)(4).Instrument has not been returned to orthopediatrics for evaluation.

Event Description

It has been reported that during the placement of a cannulated screw, a drill bit fractured when it made contact with the bone cortex.The drill bit pieces were removed.A delay greater than thirty minutes was noted.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

The follow is being submitted to relay additional information.Updated: b4: date of report: 07 feb 2020.D4: lot number: 72977-b udi: (b)(4).D10: device available for evaluation: yes.H2: additional information and device evaluation.H3: returned to manufacturer.H4: manufacture date: 18 apr 2018.H6: updated method codes: 3331, 4109 and 10.H6: updated results codes: 3211.H6: updated conclusion codes: 4315.Complaint sample was returned for evaluation.Reported event was confirmed.Investigation of the dhr did not reveal any process deviations or indications of manufacturing variations that would contribute to the observed failure mode.Risk management file review was deemed appropriate.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.

• Brand Name: 5.0MM CANNULATED DRILL BIT
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• MDR Report Key: 9696371
• MDR Text Key: 190670736
• Report Number: 3006460162-2019-00059
• Device Sequence Number: 1
• Product Code: HTW
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01-1071-038
• Device Lot Number: 72977-B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 123