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

Model Number	MTP Plate - Narrow
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 11336543
• Report Number: 9615128-2021-00001
• Device Sequence Number: 19038406
• Product Code: HRS
• UDI-Device Identifier: 07290110201692
• UDI-Public: (01)07290110201692(17)241001(10)91928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR