MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 14MM; PLATE,FIXATION,BONE

Model Number	201.364.97
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/29/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is attorney.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during the implantation procedure on (b)(6) 2015, the patient underwent an open treatment of left elbow dislocation with primary repair of anterior capsular avulsion injury, a left elbow radial head replacement for fracture and a left elbow primary repair of lateral ulnar collateral ligament.Once the injury was visible after suitable incision was made, the surgeon found an obvious clear somatic avulsion of the lateral ulnar collateral ligament off the humoral attachment point, but this appeared to be intact distally on the ulna.Radial head fracture showed almost fragments.The surgeon believed that a primary open reduction internal fixation might be the amenable, and hence proceeded to attempt the same with the goal of preserving native bone for the patient.After cleaning the wound site for better visualization of the operating site, the articular surface was lagged back together with two (2) 2.0 mm lag screws, with heads countersunk.This now stabilized the articular blocks, was dis-impacted and then a radial head locking plate was applied.Additional lateral radiographs after the provisional stabilization showed a near-perfect reduction; however, the elbow was with the elbow being fully supinated or at least in neutral position, the surgeon mentions that he underestimated the dis-impaction of the radial neck region.Without realizing this, the surgeon proceeded to stabilize it fully with combination of three (3) nonlocking screws in the shaft and five (5) locking screws in the head.Upon taking full-rotational images of the radial head in full pronation and supination, the surgeon finally realized that there was still a moderate degree of apex posterior mal-angulation which caused the anterior portion of the radial head in position of extension and did not provide adequate buttress to prevent posterior subluxation as would be necessary in the face of a multi-ligament elbow dislocation.As per the surgeon, further dis-impaction on the other hand, would have left one side of the radial head with a large fracture gap spanned by this plate construct and this would not be appropriate for the patient.Hence, the surgeon proceeded to provisionally fixate the lateral ulnar collateral ligament.The center rotation of distal humerus was identified and one (1) 3.5 mm arthrex titanium corkscrew was inserted until fully seated in bone.Once this construct was complete, the surgeon again evaluated elbow for stability.With maximal supination and extension, it still wanted to subluxate posteriorly because of the still impacted position of the anterior radial head.Radiographs taken to compare the fractured elbow and the other elbow confirmed that the alignment was not anatomically congruently reduced.Surgeon believed that any further realignment to osteosynthesis of the radial head and neck would be unsatisfactory to the patient and would likely cause nonunion and hence he aborted with the osteosynthesis of the radial neck and head, and further proceeded to radial head replacement.At this point, all implanted hardware was removed, which included the eight (8) 2.4 mm screws.Further, the surgeon restored a symmetric position of the ulnar variance with the contralateral wrist radiographs and to maintain stability of the elbow, he repaired the anterior capsular structures.Finally, the radial head prosthesis was placed in an excellent position and was confirmed with fluoroscopic images.Medial ligamentous avulsion injuries which were likely present were not repaired by the surgeon since the elbow was grossly stable.More radiographs confirmed minimal anterior subluxation still present and was noticed only with maximal pronation.The patient tripped over a trailer hitch and landed on his outstretched left elbow on (b)(6) 2015, he sustained a terrible triad fracture dislocation.X-rays taken on (b)(6) 2015 at the emergency department follow-up showed a comminuted left radial head fracture with a slight displacement visible in the ap view, and more displacement visible in the lateral view.Over time, the patient developed progressive lucency around the stem of the radial head prosthesis with proximal bone resorption consistent with a loose implant.The patient¿s pain kept worsening, as did the radiographic signs of loosening.On (b)(6) 2015, the patient presented to the hospital after his fall, and underwent a closed manipulative reduction of his elbow dislocation which was moderately stable after the reduction, particularly when splinted.Subsequently, on an unknown day between (b)(6) 2015, the patient presented to the surgeon¿s office with significant displacement and malangulation of the radial head.This predisposed him to recurrent elbow dislocation with early motion.During the surgery, the surgical wound was then stitched, and procedure completed successfully.It was unknown if there was a surgical delay.Patient outcome was stable and was found to have intact sensation median, ulnar , and radial nerve distributions.Patient had good motor function of median, anterior, interosseous, radial and ulnar nerve distributions.This complaint (b)(4) covers the intra-operative events that occurred during the implantation of the radial head prosthesis.(b)(4) covers the post-operative loosening and worsening pain leading to radial head prosthesis removal.This complaint captures the 2 out of 12 devices.Due to system limitations other 10 devices are captured under linked complaint (b)(4).This report is for one (1) 2.0mm cortex screw 14mm.This is report 1 of 2 for complaint (b)(4).This complaint involves twelve (12) devices.

• Brand Name: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 14MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7992105
• Report Number: 2939274-2018-54526
• Device Sequence Number: 1739267
• Product Code: HRS
• UDI-Device Identifier: 10886982141897
• UDI-Public: (01)10886982141897
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2018

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 Model Number: 201.364.97
• Device Catalogue Number: 201.364.97
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR