MAUDE Adverse Event Report: CONVENTUS ORTHOPAEDICS, INC. CONVENTUS CAGE PH MEDIUM; NAIL, FIXATION, BONE

Model Number	PH-M
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After removal of plate and screws from the patient arm on (b)(6) 2019, conventus performed visual inspection of the removed items and broken implant along with radiographic analysis at the time of implantation in 2016.Conventus' surgical procedure guide states that a locking screw must be used to lock the cage.Additionally, the guide requires that proximal support screws extend thru the implant to within 5mm of sub-chondral surfaces.Conventus believes that surgeon error contributed to the non-union and resultant implant failure.Based upon x-ray review, the cage was not locked and proximal support screws were left short (surgical practice not consistent with conventus ph cage surgical technique), leading to instability.Ifu language includes: tighten cage locking screw to lock cage in expanded state the wire should come close to the subchondral bone, approximately 5mm from the joint surface.Wire should be perpendicular to fluoroscopic detector for accurate measurement.Remove tissue protector and measure screw length using depth gauge.Place 2.9mm tissue protector over k-wire and drill near cortex with 2.9mm cannulated drill.Place 3.5mm cannulated screw.
Event or Problem Description
In (b)(6) 2016, the patient presented with a failed union of a two-part proximal humerus fracture fixed with competitive proximal humerus plate (implant device not manufactured by conventus).The humeral head had collapsed into varus.When and who initially performed the implantation of the competitive product are unknown.The surgeon revised the failed fracture with a conventus ph cage and plate.On (b)(6) 2017, during the follow-up appointment, the surgeon noted the humeral head was starting to fall back into varus again.The patient chose to leave the implant in place until (b)(6) 2019.On (b)(6) 2019, a conventus employee was present during the explant procedure, where the conventus cage implant was removed.After over two years with a non-union, the implant was found to have failed.After removal, some small metal fragments from the conventus ph cage device were found left behind in the post-op x-rays of the shoulder prosthesis.

• Brand Name: CONVENTUS CAGE PH MEDIUM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): CONVENTUS ORTHOPAEDICS, INC.; 10200 73rd avenue north; suite 122; maple grove MN 55369
• MDR Report Key: 8746455
• Report Number: 3008480376-2019-00001
• Device Sequence Number: 1926063
• Product Code: JDS
• UDI-Device Identifier: 00814289020709
• UDI-Public: (01)00814289020709(10)5998(17)20171117
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 11/17/2017
• Device Model Number: PH-M
• Device Lot Number: 5998
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2017
• Initial Report FDA Received Date: 06/28/2019
• 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: 54 YR