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

Catalog Number PRLSN2403

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2012

Event Type  malfunction  

Manufacturer Narrative

Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case.Dimensional examination of the product indicated it was manufactured according to specifications.It may be that excessive torque was used during tightening of the screw.The ifu document for the system instructs the user to avoid the application of high torque during screw tightening, as excessive torque may damage the bone or implants.This report is submitted following an fda inspection at the manufacturer facility.

Event Description

A piccolo composite distal volar radius (dvr) plate was implanted during (b)(6) 2012.Upon tightening one of the distal screws, a small fragment disassociated from the plate near the involved distal hole.The plate was replaced during the same surgery.

• Brand Name: PICCOLO COMPOSITE DVR 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: 6833744
• MDR Text Key: 84101746
• Report Number: 9615128-2017-00003
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: PRLSN2403
• Device Lot Number: PLT00814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2012
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2012
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2012
• 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