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

Model Number MTP Plate - Narrow

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

The involved plate was received at our facilities and underwent examination.Dimensional examination indicated the plate was manufactured according to its specification.In a microscopic inspection, a crack starting at the plate hole where the 3.5mm screw was inserted was seen.In addition, examination of production records of the involved plate did not reveal a deviation from specification.Based on the billing sheet provided, the screws used in the case were of a 3.5mm diameter.However, the piccolo composite mtp plate is indicated for use with 2.7mm diameter screws, as specified in the system ifu.

Event Description

During implantation of an mtp plate, two screws of a larger diameter than indicated were inserted into the plate holes.The plate cracked (near the hole where locking screw was inserted).The plate was removed and replaced with crossing cannulated screws.

• Brand Name: PICCOLO COMPOSITE MTP PLATE
• Type of Device: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• Manufacturer (Section G): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• Manufacturer Contact: elinor limor ; 11 ha'hoshlim st.; herzeliya, 46724-11 ; IS 4672411
• MDR Report Key: 11336543
• MDR Text Key: 252364017
• Report Number: 9615128-2021-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07290110201692
• UDI-Public: (01)07290110201692(17)241001(10)91928
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/17/2021

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: MTP Plate - Narrow
• Device Catalogue Number: MTPLN500500
• Device Lot Number: 91928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• 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
• Patient Age: 43 YR