MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP PEDINAIL; IM FEMORAL NAIL, 9MM X 34CM, LEFT

Model Number	10-1500-094
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint sample was not returned for evaluation.Reported event was confirmed through radiographic images provided by the customer.Dhr was reviewed.No deviations or rework was reported.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.
Event or Problem Description
During a scheduled hardware removal, the im femoral nail fractured when the surgeon attempted to explant it.No adverse patient issues were noted.

• Brand Name: PEDINAIL
• Common Device Name: IM FEMORAL NAIL, 9MM X 34CM, LEFT
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 9700829
• Report Number: 3006460162-2020-00016
• Device Sequence Number: 2512952
• Product Code: HSB
• UDI-Device Identifier: 00841132119235
• UDI-Public: (01)00841132119235(10)CA133712
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 10-1500-094
• Device Catalogue Number: 10-1500-094
• Device Lot Number: CA133712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 02/12/2020
• 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: Required Intervention
• Patient Age: 15 YR
• Patient Weight: 55