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

Model Number	Distal Femur Plate
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The case involved nonunion of a pathological fracture with implant failure 4.5 months post-implantation.Examination of the involved implant, as well as its production records, indicated the implant was manufactured according to specification.The fracture site suggests nail failed due to fatigue.Cases of nonunion as well as subsequent failure of the implant are known and documented in the literature [1] and are expected to be in higher rates if pathological (cancerous) bone is involved.[1] henderson ce et al, locking plates for distal femur fractures: is there a problem with fracture healing? journal of orthopaedic trauma: february 2011 - volume 25 - issue - p s8-s14.
Event or Problem Description
A distal femur plate was implanted (in the (b)(6)), to treat a pathological fracture (a metastasis was diagnosed), replacing an external fixation.Approximately 4.5 months after implantation, the plate broke.The plate was removed and replaced by a titanium retrograde femoral nail.

• Brand Name: PICCOLO COMPOSITE DISTAL FEMUR PLATE
• Common Device Name: BONE PLATE
• Manufacturer (Section D): CARBOFIX ORTHOPEDICS LTD.; 11 ha'hoshlim st.; herzeliya, 46724 11; IS 4672411
• MDR Report Key: 9334902
• Report Number: 9615128-2019-00004
• Device Sequence Number: 13921478
• Product Code: HRS
• UDI-Device Identifier: 07290109335292
• UDI-Public: (01)07290109335292(17)211001(10)91235
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K143496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: Distal Femur Plate
• Device Catalogue Number: DFELN1816
• Device Lot Number: 91235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 68