MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP ORTHOPEDIATRICS LCB 3.5 CHISEL GUIDE WITH SHORT HANDLE; INSTRUMENT GUIDE

Model Number N/A

Device Problem Material Fragmentation (1261)

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

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It has been reported that during the chiseling portion of a derotational osteotomy procedure, a piece of the chisel guide bushing was discovered to be missing.The wound was searched and a piece of the bushing was retrieved.A small piece of the bushing was unable to be found.Patient and surgical field were searched without success.No adverse events have been reported as a result of the malfunction.

• Brand Name: ORTHOPEDIATRICS LCB 3.5 CHISEL GUIDE WITH SHORT HANDLE
• Type of Device: INSTRUMENT GUIDE
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, IN 46582 ; 5742670872
• MDR Report Key: 7488162
• MDR Text Key: 107998617
• Report Number: 3006460162-2018-00028
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 01-1200-0102
• Device Lot Number: O03241401000020-AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 10 YR
• Patient Weight: 22