MAUDE Adverse Event Report: PICCOLO COMPOSITE PROXIMAL HUMERUS PLATE; BONE PLATE

Catalog Number	PPHNN3508
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fracture, Arm (2351); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The involved plate was implanted during a third surgery (revision), after two other implants (of a different company) have failed.The plate was implanted in a patient with partial resected humeral bone (an allograft was implanted together with the plate).Examination of the production records of the involved device indicated it was manufactured according to specification.The involved plate was returned to the company, and its dimensional examination did not reveal any deviation from specification.
Event or Problem Description
The involved product (proximal humerus plate) was implanted on (b)(6) 2015 during a third surgery (revision).Based on information provided to the company, the previous, removed, implants (of other companies) were stainless steel plate; and titanium nail and cage (mesh).The carbofix plate was implanted with allograft, after partial resection of the effected humeral bone.About 12 weeks after post-op., the patient complained of pain and discharge at the surgery site.In x-rays the plate was seen broken (at the area between the plate head and shaft).The patient underwent additional surgery on (b)(6) 2016.During this surgery, the involved plate was removed and replaced by two stainless steel diaphyseal plates (positioned around the humerus in 90 degrees to each other).

• Brand Name: PICCOLO COMPOSITE PROXIMAL HUMERUS PLATE
• Common Device Name: BONE PLATE
• MDR Report Key: 5646166
• Report Number: 9615128-2016-00001
• Device Sequence Number: 543063
• Product Code: HRS
• UDI-Device Identifier: 07290109333465
• UDI-Public: 07290109333465
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2016

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: Physician
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: PPHNN3508
• Device Lot Number: 90713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2016
• Initial Report FDA Received Date: 05/11/2016
• 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: 56 YR