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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• MDR Report Key: 9720753
• Report Number: 3006460162-2019-00093
• Device Sequence Number: 14053635
• Product Code: HTW
• UDI-Device Identifier: 00841132122884
• UDI-Public: (01)00841132122884(10)91801381-L
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-1050-0032
• Device Lot Number: 91801381-L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 10 YR