MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE 5.5/6.0 MINIREDUCER

Model Number 01-1300-6000

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

Customer has indicated that the product is in process of being returned to orthopediatrics for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).

Event Description

It ws reported that while reviewing the condition of the mini reducer, the hook portion of the instrument was partially missing or mangled/deformed.The portion of the instrument was too small for the surgeon to tell for certain.Intraoperative fluoroscopy was performed and no remnants were found in the patient.A post-operative plain film was performed and no remnants were found.No adverse events have been reported as a result of the malfunction.

• Brand Name: RESPONSE 5.5/6.0 MINIREDUCER
• Type of Device: REDUCER
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer Contact: kriss anderson ; 2850 frontier drive; warsaw, in ; 2686379
• MDR Report Key: 10343644
• MDR Text Key: 202752130
• Report Number: 3006460162-2020-00084
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2020

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: 01-1300-6000
• Device Catalogue Number: 01-1300-6000
• Device Lot Number: RC30716-C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 67