MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC PEDINAIL EXTRACTION ADAPTOR; EXTRACTOR

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem Pain (1994)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

Reference: (b)(4).Complaint sample was not returned for evaluation.Reported event was not confirmed.Dhr review was unable to be performed as the lot number of the involved device is unknown.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 was reported that during a planned intermedullary nail removal, the extractor stripped and alternative instrumentation was used to complete the procedure.A delay of greater than thirty minutes was noted as well as increased patient pain.No additional patient consequences were reported.

• Brand Name: PEDINAIL EXTRACTION ADAPTOR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, in ; 2670872
• MDR Report Key: 9722911
• MDR Text Key: 188716381
• Report Number: 3006460162-2019-00045
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2020

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: 01-1500-9018
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other