MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS LTD. PICCOLO COMPOSITE PROXIMAL HUMERUS PLATE; BONE PLATE

Catalog Number PPHNN3503

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2013

Event Type  malfunction  

Manufacturer Narrative

As the plate is implanted, it was not available for inspection.Although the screw did not lock to plate, fracture reduction and the end result of the implantation was satisfactory.Examination of production records of the involved plate did not reveal a deviation that may have contributed to the reported case.Testing of additional plates from the same lot of the involved plate as well as from different production lots indicated that upon application of excessive force, screw spinning may occur at one of the screw holes at plate' proximal portion.As indicated in the ifu for the system, application of high torque during screw tightening should be avoided, as excessive force may damage the bone and/or implant.The report is submitted following an fda inspection at the manufacturer facility.Device is still implanted.

Event Description

A screw did not lock to the plate.As good fracture reduction was achieved, and the implant was stable, the device remained in situ.

• Brand Name: PICCOLO COMPOSITE PROXIMAL HUMERUS PLATE
• Type of Device: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• Manufacturer (Section G): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim street; herzeliya, 46724 11; IS 4672411
• Manufacturer Contact: hila wachsler-avrahami ; 11 ha'hoshlim street; herzeliya, 46724-11 ; IS 4672411 ; 9 9511511
• MDR Report Key: 6833735
• MDR Text Key: 84108878
• Report Number: 9615128-2017-00002
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102597
• 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: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/01/2017
• Device Catalogue Number: PPHNN3503
• Device Lot Number: PLT00601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1